Associate, Regulatory Resume Sample
Nash Breitenberg
14990 Lon Shoals,
Phoenix,
AZ
+1 (555) 308 3331
Work Experience
Associate Regulatory Product & Operations Specialist
11/2017
-
PRESENT
Los Angeles, CA
- Project management and delivery of key tactical and strategic initiatives, driven by regulatory developments in the region
- Developing and supporting project plans through strategy development, project definition, and implementation
- ‘Hands-on’ on all project lifecycle activities across impacted functions in Europe to identify, document and implement solutions
- Developing end-to-end operating models, working toward regional and global consistency
- Interfacing with other control functions, the business and technology to ensure successful delivery across the Program
- Maintaining scope and enhancing structure of the wider regulatory program
- Partnering with other key Programs to ensure streamlined operating model and efficient end user experience
Senior Associate Regulatory Sciences Switzerland
11/2013
-
07/2017
Philadelphia, PA
- Implement a cross initiative data remediation and develop a strategic solution
- Act as business representative for the front office teams coordinating across the wider support functions within Private Bank (Technology, Operations, Legal, Risk etc.) to implement business solutions
- Develop and deliver updates to senior management and stakeholders
- Manage Project reporting and MIS into wider Regulatory program, tracking risk, issues and actions
- Management within Wholesale Banking
- Trading Floor personnel at all levels
- Middle office and Operations staff
Associate / Regulatory & Start
01/2009
-
05/2013
Dallas, TX
- Information Technology staff
- Members of control and infrastructure groups within CIBC, to promote the development and execution of an effective and integrated control environment
- Staff of regulatory organizations
- Interact with and manage clients by providing ongoing and proactive support and analysis
- Conduct extensive research within the environmental field
- Attend regulatory meetings on behalf of clients; perform outreach with a variety of stakeholders
- Ensure quality control of outgoing work products and correspondence
- Assist in marketing efforts, including helping in the production of summary memos, proposals, and presentations as needed
- Strong proficiency to use analytical, financial modeling and market intelligence tools such as Excel, SAP, Contract Management System, and trade capture systems
Education
University of Minnesota, Morris
2004 - 2009
Bachelor's Degree in Environmental Studies
Professional Skills
- Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams
- Effective problem solving and strong organizational skills, including ability to prioritize tasks
- Strong Microsoft Office skills with the ability to demonstrate proficiency in MS Excel
- Strong analytical skills, such as obtaining pertinent information, evaluating problems, and developing effective models
- Possesses organizational skills and ability to manage multiple priorities while working under tight time constraints
- Rapport-building skills with senior decision makers as well as broader sales and consulting stakeholders
- Good influencing & negotiation skills
How to write Associate, Regulatory Resume
Associate, Regulatory role is responsible for reporting, government, finance, training, compensation, trading, oncology, manufacturing, design, consulting.
To write great resume for associate, regulatory job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate, Regulatory Resume
The section contact information is important in your associate, regulatory 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 Associate, Regulatory Resume
The section work experience is an essential part of your associate, regulatory 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 associate, regulatory responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate, regulatory position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate, Regulatory resume experience can include:
- Responsible for writing, coordinating, overseeing, tracking and reporting on the MCRN protocol submissions, amendments, progress reports, final reports to the local and central Institutional Review Boards (IRB)
- Responsible for site or global related regulatory product management as applicable. Competent partner for site stakeholders and PTR site regulatory compliance manager
- Assess the effectiveness of processes and associated controls, identifying opportunities to remove waste and delay
- Prepares communications for approved/effective product labeling to key stakeholders
- Assisting with AML services to Irish funds and providing on-going support to other MLROs
- Monitoring regulatory developments impacting the funds industry
Education on an Associate, Regulatory Resume
Make sure to make education a priority on your associate, regulatory resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate, regulatory 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 Associate, Regulatory Resume
When listing skills on your associate, regulatory 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 associate, regulatory skills:
- Regulatory/clinical experience at a medical device company or 1+ years related experience and training
- Capability to work effectively to share responsibility as a team member
- Prior experience in a compliance support environment preferably in compensation
- Working knowledge and/or experience working in InSight, Agile or other related system
- Deliver excellent client service on a wide range of engagements, including working in the following areas
- Experience influencing teams in a global, cross-functional environment
List of Typical Experience For an Associate, Regulatory Resume
1
Experience For Associate Regulatory Product & Operations Specialist Resume
- Assessing legislative and regulatory updates and providing in-depth analysis of same to designated clients
- Acting as the main point of contact for clients with client queries and questions and responding in a confident technical manner
- Reviewing fund documentation including prospectus, business plans, programme of activities, policies and procedures
- Providing support to clients with regards to compliance, listing, corporate governance requirements and fund distribution
- Assisting and taking responsibility for FATCA responsible office services
- Support Product Labeling Leads in the maintenance of labeling regulatory / quality systems, and updating and managing electronic labeling files
2
Experience For Senior Associate Regulatory Sciences Switzerland Resume
- Work with Packaging Operations and Supply Chain to facilitate implementation of labeling for printed packaging components
- Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met
- Assist with regulatory research supporting labeling activities
- Communicate with labeling managers to ensure any new regulatory requirements are incorporated into the labeling documents
- Receive and collate labeling text from labeling team members and put text into appropriate labels
- Create compelling project communications, that are accurate, focused and actionable
- Review worldwide labeling against the Core Company Safety Information and with regard to business needs for accuracy and consistency of message
3
Experience For Associate Regulatory Submissions Manager Resume
- Manage the preparation and submission of briefing packages and CMC sections of
- Be accountable for following compliance and regulatory guidelines for producer and vendor compensation payments
- Support report owners on filing/submission of report ( i.e. Test submission, edit errors encountered upon submission)
- Coordinate responses related to questions from Health Authorities to obtain regulatory approval in a timely manner
- Critically assess current operational design and practice
4
Experience For Associate, Regulatory Supervision Resume
- Draft reports for firms and international regulators
- Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for submissions and implementation. Includes, maintaining and tracking project schedules, deliverables, timelines and activities and follow up with SMEs and project team members
- Work with cross-functional stakeholders to support timely submission, approval, and distribution of product labeling with the strategies and objectives developed by the labeling teams
- Prepare drug listing and establishment registrations for the US
- Add bookmarks, cross-references and hyperlinks when necessary to meet regulatory requirements
- Coordinate the labels, tabs, and copy process for paper submissions and prepare electronic media as required
5
Experience For Associate / Regulatory & Start Resume
- Complete regulatory agency forms and coordinate the dispatch of submissions to the regulatory agency
- Lead or support the development and implementation of global regulatory strategies for combination products and devices
- Serve as a combination product and device regulatory subject matter expert in
- Undertake short or medium-term secondments into clients to cover key control roles, typically in Compliance, Financial Crime or Risk
- Provide on the job and ad hoc advice and support to clients on a wide range of regulatory issues
- Draft reports for firms and regulators
6
Experience For Associate Regulatory Project Management Team-product & Platform Team-private Bank-geneva Resume
- Prepare articles and other publications for distribution both internally and externally
- Support PDR Program Manager and ensure that Affiliates Drug Regulatory Affairs (DRAs) in scope are informed in a timely manner, enabling dialogue and their contribution in all relevant project/program developments and activities
- Gradually assume responsibility for agreed tasks
- Process entries for payment distribution
- Accountable for the resolution of related vendor/producer issues through coordinated efforts with internal and external stakeholders
- Actively participates on special projects and responds to ad-hoc requests as required
7
Experience For Associate Regulatory Prooduct & Operations Specialist Resume
- Adhoc questions/request from Users/Report owners
- Coordinate with RegAsg/Axiomasg on user issues
- Explain/walk RegASG/Axiomasg issues encountered by users
- Lead bi-weekly mtg with Report Owners
- Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same
List of Typical Skills For an Associate, Regulatory Resume
1
Skills For Associate Regulatory Product & Operations Specialist Resume
- Experience of working in the Oncology regulatory environment in both Small and Large molecules
- Build strong collaborations and relationships with internal stakeholders to ensure successful
- Demonstrated ability to build consensus across disciplines, departments and platforms
- Experience in regulatory affairs, either in regulatory product specialist role or regulatory operations role
- Proficiency in Excel with ability to convert data for more effective analysis
- Excellent written and verbal communication; attention to detail
- Regulatory/clinical experience at a medical device company
- Strong attention to detail and possesses ability to work through ambiguity
- Drive for continuous improvements and operate with lean mindset
2
Skills For Senior Associate Regulatory Sciences Switzerland Resume
- Global regulatory experience
- Participating in and supporting the development and implementation of the regulatory strategies
- Acquiring and maintaining an overview of relevant regulatory requirements
- Undertaking research across a wide range of investment fund topics as required and providing feedback to clients
- Assisting and conducting ad-hoc projects
- Conducting on-site visits to fund service providers and writing reports
- Acting as MLRO for funds and other designated bodies
- Reviewing reports provided by auditors, administrators, custodians, distributors and investment managers to investment fund company boards
- Ensuring that deliverables are met
3
Skills For Associate Regulatory Submissions Manager Resume
- Presenting at board meetings
- Preparing regulatory submissions in collaboration with the other disciplines in PDR
- Provides regulatory labeling support including QC of labeling documents, artwork QC, translations management, and labeling project coordination
- Manage submissions, submission assembly, creating folders, adding properties, importing documents and archiving submissions
- Microsoft applications, which include working with templates, and editing and formatting complex documents
- Knowledge of vigilance reporting requirements (post market safety reporting, medical device reporting, etc.)
4
Skills For Associate, Regulatory Supervision Resume
- Review and process incoming paper and electronic documents. This includes re-formatting, and review of grammar, spelling and syntax
- Uses the enterprise strategy as the guiding principle in driving functional focus, clarity and accountability
- Preparation, approval management, and distribution of product labels including drafting initial document to SPL approval
- Perform quality checks on outgoing submissions to ensure compliance to regulatory formatting guidelines
- Assist clients with analysing the impact of new regulations on their business and helping them prepare appropriately
- Conduct reviews for a wide range of financial sector clients, following a risk based approach, identifying control failings and operational weaknesses
- Works with supervisors and managers outside of RA during the course of registration preparation
5
Skills For Associate / Regulatory & Start Resume
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product
- The ability to work with diverse groups of people, including financial professionals, home office associates, and firm management
- Managed first wave Marketing Application and/or LCM submissions in particular European centralized procedure
- Prepare and deliver training sessions both internally and for clients
- Perform quality checks in accordance with local labeling requirements (EU, US, and ROW)
6
Skills For Associate Regulatory Project Management Team-product & Platform Team-private Bank-geneva Resume
- Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components
- Manage electronic and physical labeling repositories
- Reports to a Manager of Regulatory Affairs
- Works directly with the Director and/or Manager of Regulatory affairs on FDA and European, and international regulatory matters when required
- Works with state personnel and foreign consulates/embassies personnel as appropriate
- Works with project team members and other company personnel as required
- Communicates with FDA, European Notified Body, and international regulatory counterparts regarding status of regulatory submissions and other regulatory matters
- Provide input, set milestones, and monitor progress towards results within sub-teams to achieve team goals
7
Skills For Associate Regulatory Prooduct & Operations Specialist Resume
- Basic knowledge of scientific and regulatory environment and procedures
- Demonstrable abilities to work independently or collaboratively in a team structure
- Strong capability in verbal and written communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels including presentation to Sr. Management
- Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Co-ordinate with global team for documentation
- Submission delivery strategy of all dossiers and all application types per market and /or region
- Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
- Stay abreast of changing regulatory requirements relevant to combination products/devices. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders
- Lead the creation of combination products/devices BLA/MAA model documents
8
Skills For Associate, Regulatory Global Labeling Resume
- Contribute to the newly created PTR combination product group’s vision, strategy, roadmap, and activities
- Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways
- Records and Data Management
- Successfully multi-taks
- Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
- Knowledge of ICH and cGMPs, global regulations and health authority guidance
9
Skills For Senior Associate, Regulatory Solutions Resume
- Knowledgeable in Pharma Technical Regulatory departmental processes required for scope of assignments (assigned by manager)
- Exceptional knowledge of best practices in the Regulatory industry
- Lead with inspiration and generate a culture where individuals and teams are driven to win
- Knowledge of ICH guidance documents and health authority regulations/standards relevant to
- Knowledge of software regulatory requirements and technical standards (IEC 62304)
10
Skills For Associate Regulatory Project Director Resume
- Dynamic personality, ability to think outside the box and take smart risk
- Think “big picture” and focus on details
- International and domestic travel necessary
- Discrepancy assessments. Perform discrepancy assessments within the agreed SLA with quality. Escalate potential issues to product TRL and line manager
- Provide strategic support to TRT team(s) as assigned
- Support the generation of product technical Regulatory Strategy Document (tRSD), submission metrics and project status
- Serve as a competent partner to cross-functional stakeholders and/or project teams and work effectively with multiple disciplines and management layers within the Genentech/Roche network of manufacturing sites
- Serve as an advisor to local change control bodies, support technical and supply teams on regulatory requirements and submissions strategies as assigned/as applicable
- Make changes stick by ensuring that the drivers for change are clear and understood and that change initiatives are well designed, mobilised and delivered
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