SomervilleRecruiter Since 2001
the smart solution for Somerville jobs

Associate Director, Regulatory Strategy

Company: Sarepta Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

Job SummaryJob Title: Associate Director, Regulatory StrategyDepartment: Global Regulatory AffairsReports to: Joanne Lemmo, Executive Director, Regulatory StrategyLocation: CambridgeReq : (Enter here)The Associate Director, Regulatory Strategy fosters drug development by facilitating identification and resolution of scientific and regulatory issues with the regulatory agencies. This role directs the implementation of regulatory strategy for assigned products and collaborates with other colleagues in Regulatory Affairs at Sarepta on preparation of internal teams for FDA and EMA meetings and interactions. Additionally, the Associate Director executes the preparation and submission of INDs, CTAs, NDAs, reports and correspondences to the appropriate regulatory agencies for assigned projects.Primary Responsibilities Include:Contribute to proactively formulating regulatory strategies that provide a streamlined development and approval timeline while accurately interpreting and reflecting regulatory and Corporate guidelines.Plan, prepare for, and conduct of meetings with Regulatory agencies for all assigned products.Initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.Guide project teams to implement appropriate regulatory strategies.Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.Performs other related duties as assigned.Education and Skills Requirements: B.A./B.S. or higher degree (s) in the sciences or health related field minimum, advanced scientific degree preferred, with 10 years regulatory experience.Demonstrated knowledge of drug development process is essential as is knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.Experience with preparing IND submissions and briefing packages for regulatory meetings essential.Experience with successful NDA, sNDA and/or BLA filing and working with EMA preferred.Excellent interpersonal, collaboration, written, verbal and visual communication skills.Strong analytical skills and strategic thinking. Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and attention to detail.Self-motivated with strong work ethic and the ability to work independently and efficiently.Experience working with stakeholders/partners at all levels, globally, across the organization.Proficiency with Microsoft Office Applications; Word, Excel, Outlook and regulatory systems.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Full time

Keywords: Sarepta Therapeutics, Somerville , Associate Director, Regulatory Strategy, Executive , Somerville, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


District Manager, Oncology Breast - Northeast
Description: Job DescriptionJoin a Legacy of Innovation 110 Years and CountingWith over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the (more...)
Company: Daiichi Sankyo
Location: Boston
Posted on: 01/21/2021

Associate Director, Strategic Sourcing
Description: As the Associate Director of Strategic Sourcing for Cell and Gene Therapy, you will be a part of a fast-growing and innovative organization at the company's world headquarters in Boston, MA. The Department (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Director GMP Quality - Cell & Gene Therapy
Description: In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021


Manager, Drug Product Manufacturing
Description: Vertex's Technical Operations Drug Product team has an exciting and challenging opportunity for you to facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Senior Product Marketing Manager
Description: Everbridge is looking for an action-oriented, results-driven Senior Manager of Product Marketing to develop and execute the brands product positioning and messaging. You will be the mastermind behind (more...)
Company: EverBridge
Location: Burlington
Posted on: 01/21/2021

Global Revenue Technical Accounting Senior Manager
Description: We are looking to hire a Global Revenue Technical Accounting Senior Manager. A successful candidate will have technical competence and experience in product revenue accounting and analytics as well as (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

HIA Payer Ops - Clinical Transformation Sr. Manager
Description: Line of ServiceAdvisoryIndustry/SectorHealth ServicesSpecialismOperationsManagement LevelSenior ManagerJob Description SummaryA career within Operations Consulting services, will provide you with the (more...)
Company: PwC
Location: Boston
Posted on: 01/21/2021

Strategic Sourcing, Associate Director
Description: As the Associate Director of Strategic Sourcing for Cell and Gene Therapy, you will be a part of a fast-growing and innovative organization at the company's world headquarters in Boston, MA. The Department (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Director, End User Technology Support
Description: Director, End User Technology Support - 2003529 Santander is seeking a seasoned leader to bring and drive new ideas and help to build a new foundation for End User Technology Services. Incumbent must (more...)
Company: Santander Holdings USA Inc
Location: Rockland
Posted on: 01/21/2021

Scientific Congress Lead, Associate Director
Description: General/Position Summary br br The purpose of this job is to lead the development of scientific content for all prioritized global/international congresses. With direction from the Director of Medical (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Somerville RSS job feeds