Associate Director, Regulatory Affairs
RemoteChiswick, England, United Kingdom
Job Summary
Provide regulatory operational oversight and support to expedite the development and delivery of safe and effective healthcare products globally. Guide internal teams and external clients on current Expanded Access, Open Label Extension, and Post-Approval Named Patient regulations across the US, EU, UK, and ROW. Maintain domestic licenses from competent authorities and oversee global strategy updates based on regulatory changes. Interact with regulatory authorities during review processes to ensure approvals and lead line management of staff, including leadership, training, and development. Assist in developing proposals for bid defenses and capability presentations. This role requires a Bachelor's degree, 7+ years of regulatory experience, and proficiency in Microsoft Office.
Required Qualifications
- Bachelor's degree
- 7+ years of broad regulatory experience
- Effective verbal and written communication skills
- Strong organizational skills and attention to detail
- Computer literacy and proficient in Microsoft Office
- Ability to handle extremely confidential information with complete discretion
- Pro-active and solutions driven, with ability to meet multiple tasks and deadlines with a high level of accuracy
- #LI-fulltime
- #LI-hybrid
Desired Qualifications
- legal, life sciences, or scientific equivalent preferred
- Exposure to Expanded access, Compassionate use, Open Label Extension, and Post Approval Named Patient programs preferred
- Previous experience in developing regulatory strategy
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