Associate Director Regulatory Affairs
Associate Director Regulatory Affairs
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Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Lead for one or more RA CMC development and/or globally marketed products and provide support for Chemistry Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts with responsibility 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. Provides product strategy and direction to commercial and clinical teams. Facilitates risk identification & mitigation strategies. Oversee activities of junior regulatory personnel. Manage contractual and budgetary responsibilities with best business practices.The Opportunity to Make a Difference
Serves as regulatory CMC lead for assigned product(s) for all regulatory CMC responsibilities including but not limited to the development and implementation of regulatory CMC strategy for assigned projects
Prepares and reviews submissionready CMC and marketing registration applications supplements amendments and variations
As a member of the project teams provides CMC regulatory guidance for global development and registration programs e.g. INDs CTAs NDAs and MAAs)
Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
Serves as regulatory representative for assigned projects at internal meetings as well as at meetings with regulatory agencies for all CMC related issues
Manages and ensures compliance with all reporting requirements including annual and periodic reports
Maintains knowledge of relevant evolving regulation and guidance
Global Regulatory Teams key contributor to establish and implement regulatory strategy
GDT ad hoc member
Represents Sarepta as direct contact for FDA and at global health authority meetings including assisting planning preparation for and conduct of meetings with Regulatory agencies for all assigned products
Interacts across levels and line functions to lead team through successful engagements with Health Authorities
More about You
Experience with preparing INDs IMPDs NDA and/or MAA submission(s) is essential.
This is a handson role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions.
RAC certification recommended
BS or equivalent with 10 years of related experience
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Director
Employment Type
Full-Time
