3 months ago
Hamlyn Williams is currently partnered with a cutting-edge biotech focused on the development of innovative, novel gene therapies for disorders of the central nervous system.
The client is looking to hire a Director/Senior Director Regulatory Affairs to manage all activities for clinical development of pipeline and late phase products, develop global regulatory strategies, and participate in interactions and negotiations with global Regulatory Agencies. This will be a hands-on, team-building opportunity and will be based in the Manhattan office.
- Proactively participate in design of US, EU and Canada regulatory strategies for the development of gene therapy products for rare diseases
- Collaborate with the nonclinical, clinical and CMC teams to ensure seamless integration of components in all submissions
- Lead prepraration of agency meetings and participate in negotiations
- Oversee and manage the preparation of submissions, including IND, CTA, BLA/MAA, regulatory dossiers in US and EU.
- BA/BS degree in life sciences - MS/PhD preferred
- 8-10 years of regulatory pharmaceutical product development experience, ideally in gene therapy/CNS applications
- Well-versed in regulatory strategy and regulatory science writing
- Knowledgeable in ICH, FDA, EMA and WHO regulations/guidelines
- Ability to work independently and thrive in a fast paced environment
If you are interested in more information, please reach out to Ryan at 347-305-6781 or email@example.com