Sr. Director, Regulatory Strategist
1 week ago
Report to the SVP Head of Regulatory, responsible for global regulatory strategic development. Lead, develop, and implement global regulatory strategies and provide advice on the development and life cycle management of investigational products. Prepare and manage regulatory documents, submissions, collaborating effectively with internal and external stakeholders including leading health authority interactions. Responsible for the planning, preparation, and review of content for submissions to Regulatory Agencies (e.g., INDs, CTAs, meeting requests and briefing books, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests for assigned programs, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Provide expertise in translating regulatory requirements into practical workable plans and regulatory strategies with the team based on clinical trial data, current regulations, and regulatory landscape of competitive products. Work closely with company leadership and ensure company practices conform to Regulatory Agency requirements by establishing internal documentation, control, and validation procedures.
Previous leadership role in regulatory submissions work in the US (United States), EU (European Union), UK (United Kingdom) and APAC(Asia-Pacific). Lead meetings with global regulatory agencies for major filings like NDA (New Drug Application) and MAA (Marketing Authorization Application).
Experience and Education include:
- Master's in Regulatory Affairs or foreign equivalent
- 10 years of experience (120 months) in Global Regulatory Affairs of which five (5) years of experience in filing regulatory documents related to rare diseases or with Orphan Drug designation.
Hours/Salary
Minimum of 40 Hours / Week at $234,637.81 per year
About PepGen
PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.
E-Verify
PepGen is an E-Verify Employer. For more information about E-Verify, please see here.
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