Senior Manager Regulatory Affairs CMC
Senior Manager Regulatory Affairs CMC
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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
Take the lead or colead role in RA CMC development and/or marketed product initiatives providing essential support for Chemistry Manufacturing and Controls (CMC) Regulatory Affairs. Collaborate closely with subject matter experts in CMC technical operations and QA working within a dedicated CMC subteam and serving as a key member of the GRT. Play a pivotal role in crafting highquality fitforpurpose documentation (such as INDs CTAs NDAs reports and correspondences) to facilitate interactions with global Health Authorities.You may also oversee the activities of junior regulatory personnel fostering their growth and development. Build and maintain strong relationships across global and crossfunctional teams to ensure seamless communication and efficient implementation of regulatory activities for assigned programs. Continuously apply and expand your knowledge of marketspecific regulatory procedures to drive success in your role.
The Opportunity to Make a Difference
- Contributes to developing CMC regulatory strategies for assigned projects and programs while accurately interpreting and reflecting regulatory guidelines and corporate guidelines
- Coordinates the preparation and submission of documents to appropriate regulatory agencies for assigned projects and programs to implement regulatory strategy in line with corporate goals. Responsible for completing change control regulatory assessments maintenance of regulatory tracker and submission preparation activities.
- May lead CMC submissions and agency responses.
- Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
- Required to support preparation for inspection readiness
- Maintains/further develops knowledge of relevant evolving regulation and guidance
- Global Regulatory Teams contributor to establish and implement regulatory strategy
- Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends
- Establishes and assures adherence to budgets schedules work plans and performance requirements
- Works on objectives that have major impact on functional area and the organization
- Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
More about You
- BS or equivalent 8 years relevant experience
- Experience working in GRTs and cross functional teams
- Knowledge of drug development ICH guidelines and regulatory process.
- Experience of IND/CTA IMPDs Orphan drug designation Agency Advice NDA and/or MAA submission
- Demonstrated experience with and a clear understanding of submission content and format requirements
- Ability to successfully manage projects/timelines organize/track complex information & prioritize by communicating with internal and external stakeholders
- Adaptive communication skills (including interpersonal written verbal) and able to influence others without authority
- Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
- Ability to evaluate and recommend process improvement and suggest/implement best practices.
- RAC certification recommended
- Proficiency with Microsoft Office Applications; Word Excel Outlook Adobe and regulatory/quality systems.
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:
Senior Manager
Employment Type
Full-Time
