The Senior Director/Executive Director of Regulatory Affairs will be responsible for developing and executing regulatory strategies for all assets at various stages, including IND, NDA, and life cycle management activities across our client’s portfolio. This role requires a highly self-motivated individual who can thrive both independently and as part of a dynamic team in a fast-paced environment. Strong initiative and follow-through are critical.
Key Responsibilities:
- Develop and implement regulatory strategies and contingencies for global product development, including investigational, licensing/registration, and post-marketing support.
- Provide regulatory support and guidance during team meetings.
- Offer expertise and strategic advice to senior management and other departments on regulatory matters, ensuring the successful planning, compilation, and submission of all regulatory filings.
- Communicate timely updates on regulatory interactions to senior management and other internal stakeholders as appropriate.
Qualifications:
- Education: BA/BS degree in life sciences; MS, PhD, or other relevant advanced degree preferred.
- Experience: Minimum of 10 years in drug development, including at least 5 years in regulatory affairs roles with increasing responsibilities.
- Skills: Strong knowledge of global drug development and regulatory policies, with demonstrated expertise in regulatory-focused drug development.
- Knowledge: In-depth understanding of US regulations governing the pharmaceutical industry, as well as comprehensive knowledge of drug development processes, including clinical trial design, statistics, and clinical pharmacology.
To apply:
Please apply via LinkedIn and attach your CV and contact information to Cara.Baker@morganprestwich.com
