Senior Manager, Regulatory Affairs Resume Sample
Joanie Jones
3510 Morissette Mountains,
Chicago,
IL
+1 (555) 758 5219
Work Experience
Senior Manager, Regulatory Affairs
05/2016
-
PRESENT
Houston, TX
- Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects.
- Demonstrated knowledge of regulatory issues, and experience interfacing with local and international regulatory bodies, such as FDA, European competent authorities & notified bodies, etc
- Read, analyze, and interpret governmental regulations and laboratory / test reports
- Demonstrated ability to work independently with new, complex technologies and produce professional work products
- Familiarity and ability to work with office automation programs and corporate database tools
- Local management of ‘product holds’ and field corrective actions
- Participate in project team meetings updating status of Regulatory Operations activities, represent the company’s Regulatory Operations group in internal and external development project meetings and contribute to the establishment of regulatory strategies for new products and processes
- Directs functional activities designed to achieve rapid worldwide clearance/approval/registration of DC products with desired claims
- Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA, NSAI and other regulatory agencies
Senior Manager Regulatory Affairs
07/2011
-
12/2015
Detroit, MI
- Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
- Directs RA associates in the preparation of PMAs, 510(k) s, Technical Files/Documentation, and documentation for ex-U.S. registrations; oversees international registration activities for DC
- Represents DC in interactions/negotiations with U.S. regulatory agencies and enables and empowers staff to interact and negotiate with regulators as well
- Monitors regulatory developments affecting DC programs and communicates emerging opportunities and concerns to stakeholders (e.g. supervisor, DC Leadership Team and Project Teams)
- Represents DC in external activities benefiting DC and BD (e.g., standards organizations)
- Manages staff of regulatory professionals carrying out product submission/registration activities
- Hires, develops, and retains staff to meet overall functional and product development/lifecycle management needs
Senior Manager, Regulatory Affairs Operations
04/2007
-
01/2011
Houston, TX
- In collaboration with supervisor, evaluates resource requirements based on business strategies, objectives, and priorities and allocates resources accordingly
- Designs and implements training on regulatory issues for staff and for business stakeholders (e.g., Clinical Affairs, R&D., Marketing)
- Develops RA associates’ skills in project management, effective team participation and communications
- Manages the regulatory review of labeling and promotional materials
- Reviews clinical protocols and reports to assure collection of appropriate data for regulatory submissions
- Ensures FDA device listings and facility registrations are maintained
- Ensures that RA departmental policies, procedures, and records comply with applicable regulations and standards
Education
University of New Mexico - Taos Campus
2002 - 2007
Bachelor's Degree in Science
Professional Skills
- Demonstrate strong skills to organize, prioritize, and execute
- Strong leadership skills, experience in a matrix organization and culturally diverse working environment
- Demonstrates strong communication and influencing skills, both internally and externally with peers in other departments and at partner organizations
- Demonstrates solid organizational skills, including the ability to prioritize personal workload
- Demonstrate effective cross functional and cross cultural skills including ability to impact industry/agency organization decisions
- Demonstrated planning and organisation skills
- Excellent writing and verbal communication skills across all levels
How to write Senior Manager, Regulatory Affairs Resume
Senior Manager, Regulatory Affairs role is responsible for interpersonal, regulatory, organizational, organization, influencing, negotiation, english, software, government, education.
To write great resume for senior manager, regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Manager, Regulatory Affairs Resume
The section contact information is important in your senior manager, regulatory affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Senior Manager, Regulatory Affairs Resume
The section work experience is an essential part of your senior manager, regulatory affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous senior manager, regulatory affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior manager, regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Manager, Regulatory Affairs resume experience can include:
- Remains current on regulations affecting DC products (MDD, IVD, RUO/IUO policies, CLIA, reclassification activities, etc.) and keeps an open line of communication to supervisor on ongoing initiatives
- Excellent English and German communication skills
- Exceptional analytical and problem solving skills; extensive medical, scientific and/or technical knowledge pertaining to pharmaceutical development or
- Strong understanding of the regulatory environment in China and a good working relationship with CFDA
- US drug compounding (FDA 503A and 503B) regulatory and GMP experience. State Board of Pharmacy experience helpful
- Proven experience in applying regulatory knowledge to various situations
Education on a Senior Manager, Regulatory Affairs Resume
Make sure to make education a priority on your senior manager, regulatory affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior manager, regulatory affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Senior Manager, Regulatory Affairs Resume
When listing skills on your senior manager, regulatory affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical senior manager, regulatory affairs skills:
- Demonstrates inclusive and effective cross-functional and cross-cultural skills to successfully drive regulatory strategies, especially in emerging markets
- Experience interfacing with government regulatory agencies and proven skill at implementing successful global regulatory strategies
- Plan, mentor, and perform regulatory and quality work in the medical device industry with strong analytical and critical thinking skills
- Strong computer skills and ease of adapting to new electronic systems
- Strong leadership, decision-making and managerial skills
- Demonstrate the ability to work independently and within a group setting, and to interact effectively with various functional groups
List of Typical Experience For a Senior Manager, Regulatory Affairs Resume
1
Experience For Senior Manager Regulatory Affairs Resume
- Experience in leading Health Authority Interactions and negotiations, with superior communication and influencing skills
- Grow, develop and effectively manage a team to ensure good retention and on-time submissions/approvals
- Operate effectively in a culturally diverse organization and with global teams
- Demonstrated interpersonal and collaboration skills; proactively influences and negotiates to achieve strategic goals and objectives
- Development of strong partnerships with internal stakeholders to engage effectively on regulatory response
- + Strong interpersonal and analytical skills
- + Excellent written and oral communication skills
- + Excellent organizational and multi-project management skills
2
Experience For Senior Manager, Regulatory Affairs CMC Resume
- Motivated team player with excellent organizational skills
- Very good English skills, German and other languages are an asset
- Excellent organizational and multi-project management skills, with specific attention to detail
- Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Prior relevant experience in pharmaceutical Regulatory Affairs including development, registration and lifecycle management of pharmaceutical products
- Proven ability to establish strong working relationships with cross-functional stakeholders
3
Experience For Senior Manager Regulatory Affairs & Project Mgmt Resume
- + Demonstrated experience in preparing global regulatory submissions - PMAs, IVE's, 510(k)
- Experience with good manufacturing practices (GMP)
- And demonstrated experience with multi-tasking
- Develop and effectively communicate regulatory strategies for assigned products
- Demonstrated ability to work with changing priorities that involve multiple and concurrent projects
- Communicate effectively, orally and written
- Responsible for ensuring effective implementation of filing plan, publishing and archiving of documents
- Strong strategic thinking, problem-solving and analytical ability
4
Experience For Senior Manager, Regulatory Affairs Operations Resume
- Excellent working knowledge of medical device regulations (21CFR), FDA law and CE marking
- Experience in negotiating with FDA personnel in the device (CDRH) and biologics (CBER) areas
- Well-organized, accustomed to high standards of written and verbal communication and maintaining excellent records of correspondence with regulatory bodies
- + Experience authoring 510(k)
- Experience and knowledge in the preparation of major global regulatory submissions including license applications, supplements/variations, and amendments
- European CE marking experience. Class IIa/IIb Technical File
- Experience in supporting international registrations
- Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure
5
Experience For Senior Manager Regulatory Affairs, DEA Resume
- Provide regular and timely performance feedback to direct report associates to actively develop and improve their skill sets
- Experience with reviewing promotional materials and product information, ideally in an information officer role
- Typically, 9+ years regulatory affairs experience in the medical product industry
- Proven track record of managing positive interactions with the FDA and other regulatory authorities
- Results oriented, positive “can do” attitude with a demonstrated a sense of urgency
- Strong capability to contribute and lead a team environment
6
Experience For Manager / Senior Manager Regulatory Affairs Resume
- Relevant pharmaceutical industry and regulatory experience
- Experience working in a complex and matrix environment is required
- Demonstrate the ability to research and analyze information and develop regulatory strategies
- Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities
- Experienced in filing NDSs, SNDSs, Post-approval Changes and Administrative submissions
- Plan and manage complex projects and prioritize workload
7
Experience For Senior Manager, Regulatory Affairs Global CMC Resume
- + 7 years experience in Regulatory Affairs medical device arena, Class II devices
- + Management experience required/Exceptional leadership capabilities
- Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe
- Proven ability to lead cross functional CMC teams on projects and sub-teams
- Working knowledge of regulations for infusion pumps and associated devices
- Working knowledge of 21 CFR Parts 803, 806, 820, 860, Canada Medical Device Regulations and EU Medical Directive requirements
- Developing regulatory strategies for global markets
- Understanding of GXP practices, including regulatory documentation quality processes
- Working knowledge of electronic filing/e-CTD dossier preparation
8
Experience For Senior Manager Regulatory Affairs EU Resume
- Understanding of regulations for sterile disposable products
- Direct and oversee the work of regulatory professionals, including training, mentoring and insuring professional development
- Provide regional Regulatory strategy for submitting the aforementioned complex submission including identifying potential risks and gating factors
- Manage CN’s handling of Transport Canada Rail Safety S31 Notices and Orders and HRSDC Directions including ensuring response by deadlines
- Responsible for tracking and communicating regulatory activities within RA and for ensuring that submission plans are captured accurately
- Reviews domestic and international labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc
- Participates as a cross-functional team member helping to facilitate actions and communications involving field corrective actions
- Interacts with stakeholders at varying levels concerning matters of significance to the company
- Support product engineering/manufacturing staff to review, assess and approve product modifications to determine appropriate regulatory requirements
9
Experience For Senior Manager, Regulatory Affairs, CMC Resume
- Review and approve customer publications, labels, marketing, advertising and/or promotional materials for compliant and accurate content
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
- Thorough understanding of relevant drug development and post-marketing regulations and guidelines and
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Participate/facilitate relevant functional area and project team meetings, including nonclinical and clinical/regulatory subteams
- Develops Global RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met
10
Experience For Senior Manager Regulatory Affairs Category Resume
- Maintains a thorough working knowledge of US, Canada, EU and International laws, regulations, standards, guidance and guidelines
- Manages and develops team of Regulatory professionals. Provides appropriate mentoring, appraisals, and discipline of direct reports
- Direct communication with regulatory authorities regarding company’s regulatory filings
- Create and update departmental standard operating procedures (SOPs)
- Maintains and updates PCRC and other related SOPs; prepares and conducts training on SOPs where applicable
- If applicable, oversees preparation of product labeling and Company Core Data Sheets for Pacira Products
List of Typical Skills For a Senior Manager, Regulatory Affairs Resume
1
Skills For Senior Manager Regulatory Affairs Resume
- Skills and experience to represent the GEM group on project teams
- Prioritize effectively and organize complex information
- Outstanding stakeholder management and organizational skills
- Conveys trust in others’ knowledge, skills & judgment & provides team members with appropriate levels of autonomy & decision-making authority
- Strong working knowledge and experience with current FDA medical device regulatory requirements and EU MDD & MDR requirements
- Strong background and history of managing projects and/or individuals, with proven track record of successful outcomes
2
Skills For Senior Manager, Regulatory Affairs CMC Resume
- Expertise in managing regulatory affairs and the ability to effectively interpret and manage regulatory obligations
- Proven experience in interactions with regulatory bodies
- Experience with coaching, training and mentoring team members
- Are comfortable in driving continuous improvement initiatives, have strong problem solving ability and commercial acumen
- Experience reviewing promotional and advertising materials
- Experience of leading projects through Regulatory Procedures, ideally large Phase 3 programmes
- Experience of managing international submissions
3
Skills For Senior Manager Regulatory Affairs & Project Mgmt Resume
- Experience in preparing FDA and EU product submissions required
- Substantial experience with multitasking in a deadline controlled and highly regulated environment
- Experience managing execution of multiple projects
- Foster a strong team environment, while recognizing the needs of team leaders and key stakeholders
- Experience and knowledge in the preparation of major regulatory submissions supportive amendments, supplements and labelling lifecycle management
4
Skills For Senior Manager, Regulatory Affairs Operations Resume
- Good knowledge and understanding of applicable regions
- Seven (7) years experience working in the medical device industry
- Experience working with new product development teams, and substantial knowledge of Design Controls
- Experience analyzing technical and scientific data and reports
- Knowledge of and experience with FDA Human Factors Engineering
- Strong background in chemistry, molecular biology, or similar is desirable
- Preferably experience with regulatory activities in Latin America and with Headquarters-led projects
- Understand customers’ goals and priorities as a means to ensure customer satisfaction
- Experience in liaison with major regulatory Agencies
5
Skills For Senior Manager Regulatory Affairs, DEA Resume
- Experience in Dietary Supplement/Food regulatory environment
- Manage projects of high-complexity and prioritize actions based on clear and pragmatic criteria
- Extensive experience with pre- and post-approval requirements with EMA, FDA
- Broad experience with regulatory documents (files, annual reports, investigations, process changes)
- Excellent Command of German and English (spoken and written)
- Experience in regulatory CMC
- Experience with submissions across product development
6
Skills For Manager / Senior Manager Regulatory Affairs Resume
- Five (5) years experience in global Regulatory Affairs for medical devices
- Assessing an appropriate regulatory path based upon global business strategies
- Working familiarity with Over the Counter (OTC) regulations
- Manage work team performance, including individual performance coaching and participate in delivery of period performance feedback/reviews
- Set requirements, review and approve product labeling and literature, advertising and promotional materials
- Facilitate agreement with others through listening and understanding their perspectives
- Track record of leadership, providing sound judgment/ideas and business partnering
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Development of new Regulatory Affairs Associates into fully contributing staff
7
Skills For Senior Manager, Regulatory Affairs Global CMC Resume
- Knowledge of development, manufacturing and analytical technology for both small molecules and biologicals
- Liaison with business leads to discuss strategic planning and collateral material needs and timelines
- Work with process/system for review of collateral materials including regulatory input to key material
- Maintain expert knowledge of applicable Federal and foreign regulations pertaining to regulatory actions
- Advise business on marketing claims and strategic roadmaps
- Regulatory solutions taking financial responsibility into account
- Availability and flexibility for national and international traveling
- Knowledge and understanding of different phases of drug development
8
Skills For Senior Manager Regulatory Affairs EU Resume
- Results-oriented and have a track record of completing deliverables on time with high quality
- Business acumen – willing to exhaust Reg. options in compliant way to maximize business opportunity
- Sound basis of Scientific (Training/Communications) knowledge in multiple areas
- Provide timely and high-quality medical input to business teams and achieve the following responsibilities
- Act as the point of contact for Regulatory Agencies for asset(s); Plan and lead activities associated with FDA meetings pertaining to a project/product
- Typical work-related travel assignments range 1-5 days (overnight, out-of-town stays are required)
- Communication of regulatory strategies such that expectations are understood
- Anticipate regulatory agency responses to strategy
9
Skills For Senior Manager, Regulatory Affairs, CMC Resume
- Knowledge of Therapeutic area for assigned projects
- Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively and demonstrate optimism and energy in the face of change and adversity
- Represent the department in project teams
- Strong project management skills, written and oral communication skills, and an in depth and working knowledge of FDA and EU regulatory history, guidelines, policies, and standards
- Proficient in MS Word, Excel, Power Point, and Outlook required
- Review and approve change notices, specifications, batch records, standard test
- Timely submissions and expeditious approvals within a compliant framework for generic drugs for the US market
- Broad knowledge of local and international GMP requirements
10
Skills For Senior Manager Regulatory Affairs Category Resume
- Manage processes and regulatory teams/individuals for advising project/development teams on regulatory needs, reviewing plans aimed at delivering submission materials and generating necessary submissions to achieve business success
- Manage communications with key internal process owners and external regulatory agencies, trade associations and customers
- Recruit, develop, and mentor regulatory and quality professionals
- Lead process improvement projects within regulatory affairs
- Read, analyze, and interpret regulatory literature and documents
List of Typical Responsibilities For a Senior Manager, Regulatory Affairs Resume
1
Responsibilities For Senior Manager Regulatory Affairs Resume
- Strong communication skills, with ability to get their point across clearly and simply; able to articulate an overwhelming business case
- Critical thinking skills and ability to follow-through
- Participate on multidisciplinary product development teams and communicate regulatory requirements effectively
- Establish strong working relationships within the project teams by proactively managing global CMC strategies, submissions, and timelines
- Strong understanding of Bio CMC development and DS / DP manufacturing
- Validate product labelling for Canadian market as per appropriate regulations
2
Responsibilities For Senior Manager, Regulatory Affairs CMC Resume
- UndergraduateDegree, MSc, PhD with more than 7 years regulatory experience in an industry setting
- Experience with operational planning and communications tools (e.g., Microsoft Plan, SharePoint)
- Regulatory/labeling experience
- Experience with the drug development process and regulatory knowledge
- Experience working in a highly matrixed, global and multi-site environment
- Prepares and delivers effective presentations for internal audiences
- Conduct appropriate research to develop strong regulatory strategies for new products
- Provides input into development of processes to leverage Allergan global processes and infrastructure and maximize efficiency and effectiveness
- Manages quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution
3
Responsibilities For Senior Manager Regulatory Affairs & Project Mgmt Resume
- Oversee various compliance activities / processes as needed including employee training on regulatory topics
- Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestones, and activities for agency filing
- Contribute to the business by providing overall regulatory strategy guidance and execution that ensures compliance
- Establish targets, assesses performance, define training needs and development plan for Canadian Regulatory Affairs Manager
- Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices
- Provide critical review of all documentation supporting regulatory applications
- Prepare and oversee as necessary the preparation of European registrations for new or modified products; CE marking, design/technical dossiers, etc
- Define, monitor, collate, and publish deliverables for submissions in coordination with divisional BSH and EMEA marketing and sales teams
4
Responsibilities For Senior Manager, Regulatory Affairs Operations Resume
- Analyze and manage post market incident reporting activities
- Develop a product regulatory timeline aligned to product development, with key regulatory milestone, and activities for submission filing
- Participate as a member of the product development team(s) to build awareness of Regulatory Authority/NB requirements and timing for submissions
- Manage interactions with other (e.g., Quality, Compliance) during Regulatory Authority inspections
- Develop a product regulatory timeline aligned to product development, with key regulatory milestone, and activities for agency filing
- Comply with all reporting requirements such as annual reports and yearly biologic periodic reports
- Implement policies to ensure ongoing compliance of regulatory requirements
- Actively participate in project team meetings and provide leadership in meeting submission goals
5
Responsibilities For Senior Manager Regulatory Affairs, DEA Resume
- Identify and manage resolution in collaboration with management to routine and complex issues including regulatory risk and provide risk/benefit strategies
- Regularly review regulatory intelligence and FDA websites to staying current with changes in regulatory guidelines and rules
- Provides regulatory review and approval for domestic and International product marketing communications
- Provide input into CMC regulatory strategy for development products working closely with the Product Lead
- Develops cross-departmental processes, build interdepartmental relationships, and team building
6
Responsibilities For Manager / Senior Manager Regulatory Affairs Resume
- + Ensure the timely and accurate filing of global regulatory documentation
- + Interface with FDA, TUV, other regulatory agencies and consultants regarding regulatory submission strategy and approval reviews
- + Provide guidance regarding regulatory strategy and requirements, as requested
- Ensure the timely and accurate filing of global regulatory documentation
- Interface with FDA, TUV, other regulatory agencies and consultants regarding regulatory submission strategy and approval reviews
- Provide guidance regarding regulatory strategy and requirements, as requested
7
Responsibilities For Senior Manager, Regulatory Affairs Global CMC Resume
- Lead the execution of our strategies in a cross-functional approach internally and with key stakeholders externally
- Govern and lead BU SRA teams on EU food regulatory matters and proactively manage priority topics in a collaborative approach across the European territory and beyond where those matter
- Provide leadership in industry and scientific organizations to help advance the Company’s scientific and regulatory agenda
- Work with European Institutions/regulators, scientific organisations, NGOs and other key opinion leaders
- Closely interact within the global SRA community, PAC, R&D, Legal, Marketing, Technical Governance functions and with other Business Unit Function Leaders, Bottlers, key suppliers and customers
- Proactively inform Sr. SRA Leadership, business unit partners and cross-functional business partners about scientific and regulatory emerging issues to increase their understanding of issues and influence business strategies and formulates plan of action to mitigate risks and materialise opportunities
- Directs, coordinates and prioritizes the daily activities of the assigned staff
- Flexibility to adjust to changes in schedule, priorities, product availability and perform multiple tasks simultaneously
8
Responsibilities For Senior Manager Regulatory Affairs EU Resume
- Responsible of product composition validation under Canadian regulations
- Validate product’s claims under Canadian regulations
- Coordinate the validation process for Vega products (Canada, US and other countries)
- To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines
- Independently manage multiple projects and submissions primarily for Alexion’s commercial and investigational products
- Reviews and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s
9
Responsibilities For Senior Manager, Regulatory Affairs, CMC Resume
- Interacts with various departments as needed on regulatory issues and/or strategy
- Manage the regulatory associates in the preparation, compilation and submission of high quality: supplements, annual reports, control documents, etc. to FDA authorities
- Critically reviews regulatory submissions and assigns signature for approval
- Interacts between departments to coordinate and facilitate submissions
- Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met
- Evaluates changes to regulatory documents and formulates a strategy to ensure proper filing categories
- Works to minimize regulatory issues and helps prevent unnecessary regulatory delays
10
Responsibilities For Senior Manager Regulatory Affairs Category Resume
- Coaches, mentors and provides guidance to the regulatory associates
- Represents Regulatory Affairs on project teams interdepartmentally
- Interacts with FDA and all of the company sites via written and phone communications
- Contribute to the strategy, planning, preparation, submission and maintenance of MAA’s, CTA’s, ODD’s, PIPs, Regulatory Agency meetings, Protocol Assistance etc as required for assigned programs
- Monitors and maintains awareness of the US regulatory and legal environment, particularly with respect to advertising and promotional review of pharmaceuticals and other medical products; assesses impact to business; interprets and disseminates information to affected departments across the company
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