Associate Director Regulatory Affairs CMC
Associate Director Regulatory Affairs CMC
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$ 156000 - 195000
1 Vacancy
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
Reporting to the Director CMC this position will provide support for Chemistry Manufacturing and Controls (CMC) Regulatory Affairs for development and commercial gene therapy products. Lead submissions with minimal supervison for one or more RA CMC development and/or 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 CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and in high quality. This position provides product regulatory CMC strategy and direction to Tech Ops Quality commercial and clinical teams internally and agency engagement and alliance partner interactions externally.The Opportunity to Make a Difference
- Serves as regulatory CMC lead or support 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 writes and reviews submissionready CMC and marketing registration applications supplements amendments and variations
- As the primary or supportive regulatory CMC representative member for assigned projects provides CMC regulatory guidance for global development and registration programs (e.g. IND/IMPD/CTAs NDA/BLA/MAAs). Attends internal meetings as well as regulatory agencies meetings
- Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
- Manages the review comments resolution and approval process to ensure ready for transfer to Reg Ops for subsequent activities
- Identifies areas to implement innovative regulatory strategies to support Sareptas objectives
- Participates in Global Regulatory Teams
- Contributes to with the ability to own SOPs and internal regulatory quality procedures
More about You
Must thrive working in a fastpaced innovative environment demonstrating flexibility and a proactive approach. Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders. Ability to manage conflict and analyze complex issues to develop relevant and pragmatic plans programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues to a broad audience.
- BS or equivalent with 10 years of related experience.
- Experience with preparing INDs IMPDs BLA NDA and/or MAA submission(s) is essential
- Handson role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions
- Experience working in a matrix environment and excellent people skills
- RAC certification recommended
- Excellent interpersonal collaboration written verbal and visual communication skills with ability to influence crossfunctionally at all levels within the organization
- Solid sense of accountability sound judgement and strong attention to detail
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
