Posted in Other 26 days ago.
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Type: Full Time
Location: Cambridge, Massachusetts
The Sr. Manager, CMC Regulatory Affairs reports to the Senior Director, the head of Regulatory CMC RNA platform and is responsible for managing RNA CMC projects and providing support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed small molecule products. The Sr. Manager works closely with subject matter experts and is responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. This is a hands on role requiring strong knowledge and experience in the writing and the overall prepation of CMC sections of regulatory submissions. This position provides product strategy and direction to commercial and clinical teams.
Primary Responsibilities Include:
* Prepare and review submission-ready CMC and marketing registration applications, supplements, amendments and variations.
* As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g. INDs, CTAs, NDAs and MAAs).
* Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
* Serve as regulatory representative for assigned projects at internal meetings as well as at meetings with regulatory agencies for all CMC related issues.
* Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
* May manage contract staff and vendors as needed to support Regulatory activities.
* Perform other related duties as assigned.
Education, Knowledge and Skills:
* Bachelor s degree required, M.S. or Ph.D. preferred, in a biomedical discipline with at least 7 years of regulatory experience supporting both development projects and marketed products (or 4+ years with M.S. or 2+ years with Ph.D.).
* Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential.
* Established working knowledge of regulatory guidelines and regulations (US and international).
* Regulatory experience supporting both development projects and marketed products.
* Prior hands on experience of FDA CMC regulatory submissions is essential.
* Strong knowledge of eCTD elements and structure and regulatory writing skills.
* Experience working in a matrixed global environment with excellent interpersonal skills are required; must be able to thrive in a fast-paced, innovative environment where proactivity and flexibility is expected.
* Possesses strong verbal communication and presentation skills; excellent analytical skills and an ability to communicate complex issues to a broad audience.
* Experience working with all levels of management and consulting with key business stakeholders.
* Strong team player that has a customer service approach and is solution oriented.
* Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
* Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly.
* Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details.
* 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.