This clinical-stage biotech company is developing innovative treatments for multiple neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease. They are seeking a Senior Regulatory Affairs Consultant who can contribute to their regulatory strategy, and lead meetings with various Health Authorities.
This engagement may require up to 20 hours a week initially, and may vary in time commitment for the remainder of 2026. This is a remote role with some regular travel to the client’s office in Pennsylvania, as well as potential travel to EU and possibly FDA for meetings.
Responsibilities:
- Contribute to development of a global regulatory strategy for the company’s neuroscience programs.
- Contribute to preparation and execution of meetings with EU regulatory authorities to gain Scientific Advice on the development programs and planning the path to registration.
- Contribute to the planning and compilation of critical documentation related to US and EU NDA submissions.
- Emphasis on Clinical Pharmacology, Clinical and Statistical documentation, and drafting prescribing information.
Qualifications:
- Advanced degree (e.g., MS, PharmD, or PhD) required with a minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry, with a focus on Clinical Pharmacology, Clinical and Statistical regulatory matters. Experience in CNS/Neurology programs is highly desired.
- Experience preparing for and leading meetings with Health Authorities (including FDA, EMA and EU member states) and a track record of successful interactions.
- A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines to allow for creative strategies in gaining agreements with health authorities and achieving goals within a small company environment.
- Experience supporting both early and late phase development, including development and filing of associated regulatory submissions. Recent NDA preparation and submission required.
- Must be familiar with current regulatory legislation, industry trends, and regulatory practices, including but not limited to the US and EU.
- Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, and workload prioritization.
- Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively.
NOTE: Consultants in the Northeast are strongly preferred. All applicants must be authorized to work in the United States. We cannot support H1B transfer for contract positions.