An early stage, clinical research pharmaceutical company based in Berkeley Heights, NJ is looking to hire for a Director/Head of Regulatory Affairs.
This company is focused in the therapeutic areas of oncology, renal disease, and bone/joint disease. They pride themselves on their cooperation with other pharmaceutical organizations, currently working with another global pharmaceutical company to pursue innovative biopharmaceutical, antibody, and molecular-targeted research technologies. One such example is their recent partnership to develop a digital solution for pain management in patients with endometriosis.
The Head of U.S. Regulatory Affairs will be responsible for leading regulatory strategy development and operational management for the company's clinical programs of early phase drug products. They will also manage the company's interactions with the FDA, provide guidance to cross functional teams/departments, and ensure regulatory strategy is in keeping with both US and Global regulatory standards.
Responsibilities:
* Lead regulatory affairs team to develop effective regulatory strategies for products in early development in multiple therapeutic areas.
* Provide guidance to ensure that regulatory project objectives and milestones set are met.
* Provide direct supervision, support, and mentorship of US Regulatory Leaders and other staff.
* Manage and participate in the creation, review, assembly and submission of regulatory documentation such as INDs, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials.
Required Experience:
* Bachelor's degree in life sciences, chemistry, or related discipline
* 10 - 15 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
* Understanding of both the US and global regulatory environment.
* Expertise in all aspects of the drug development process (taking a molecule from pre-clinical to FDA approval).
* Strong background in biologics background is preferred.
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Director, Head of U.S. Regulatory Affairs
- Location New Jersey
- Job type Permanent
- Salary Negotiable
- Discipline Regulatory
- Reference PR/282231_1605736657