Associate Director, Cmc Regulatory

2 months ago

Cambridge, United States Sarepta Therapeutics Full time

Co-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners.

Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Develops and delivers on fit for purpose high quality documentation (e.g., IDEs, IVDR documents, PMAs, reports, and correspondences) to support successful global Health Authority interactions. Facilitates risk identification & mitigation strategies. Oversees activities of junior regulatory personnel. Manages contractual and budgetary responsibilities with best business practices.

Primary Responsibilities Include:

- Working with diagnostic partners to mutually align on co-development regulatory needs and determine regulatory paths toward development and global registration activities
- Develops fit for purpose regulatory strategies incorporating totality of development and driving engagements that result in high value feedback from global health authorities and support Corporate objectives
- Represents Sarepta as direct contact for FDA and at global health authority meetings including a planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products
- Interacts across the Regulatory department and other line functions to lead team through successful engagements with Regulatory Agencies
- In collaboration with Regulatory project lead, responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products
- Ensures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, and scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review
- Guides clinical and nonclinical study teams to implement appropriate regulatory strategies
- Coordinates and manages regulatory activities required for submissions to regulatory agencies for assigned products
- Maintains knowledge of relevant evolving regulation and guidance
- Global Regulatory Teams - lead team to establish and implement multi-disciplinary regulatory strategy
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
- Works on objectives that have critical impact on functional area and the organization
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
- Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities
- Expected to present and contribute to presentations at governance committees including Research and development Committee, the Executive Committee, and the Communications Committee

Desired Education and Skills:

- Experience in device or drug/device combination product regulatory framework, global experience is preferred
- Knowledge of product labeling for devices
- Demonstrated knowledge of drug development process. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
- Experience with preparing regulatory submissions and briefing packages for regulatory meetings
- Personal leadership, with an ability to bring divergent views together, agree on common objectives and engenders enthusiasm even in challenging circumstances. Leading without authority
- Able to effectively communicate on regulatory topics both internally and externally
- Shows flexibility and is open to adaptable to change
- BS or equivalent with 10+ years of related experience
- Prior regulatory affairs experience in major markets is expected

LI-Remote

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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