Planet Pharma
Senior Director, Regulatory Affairs
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Join Our Team as Senior Director, Regulatory Affairs
Are you an accomplished regulatory professional ready to lead groundbreaking initiatives in the biotech and gene therapy space?
We are seeking a strategic and dynamic Senior Director of Regulatory Affairs to serve as a global leader in the development and registration of innovative gene therapy products. This pivotal role offers the chance to own major regulatory strategies for late-stage therapies and directly influence global filings, supporting a rapidly growing biotech poised for success.
Key Skills & Qualifications
- Over 10 years of regulatory affairs experience, with a focus on biologics and clinical regulatory affairs.
- Proven expertise supporting late-stage development with international regulatory agencies, including EMA and MHRA.
- Extensive hands-on experience with BLA or MAA submissions, and interacting directly with FDA, EMA, and MHRA.
- Strong knowledge of global regulatory environments and strategic planning in a biotech setting.
- Exceptional communication, organizational, and stakeholder management skills.
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Nice-to-Have Skills
- Experience with gene therapy, cell therapy, or AAV platforms.
- Prior BLA submission experience.
- Familiarity with fast-track and specialty designation applications.
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Preferred Education & Experience
- Bachelor's in a scientific discipline; advanced degrees (PharmD, PhD) preferred.
- Significant industry experience with increasing leadership responsibility.
This is a unique opportunity to lead global regulatory initiatives in a lean, innovative environment. If you thrive on ownership, strategic influence, and advancing cutting-edge therapies, we encourage you to apply and make a meaningful impact in the field of gene therapy.
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