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Senior Manager – Regulatory Affairs
| Company | Sarepta |
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| Location | Cambridge, MA, USA |
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| Salary | $132000 – $165000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- 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
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems.
- BS or equivalent, 8+ years relevant experience
Responsibilities
- Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs.
- 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.
Preferred Qualifications
- RAC certification recommended
