Senior Regulatory Affairs Manager – Ewing, NJ
The Senior Regulatory Affairs Manager will report to the Head of Regulatory Affairs and will work collaboratively with this person to help develop strategic and operational aspects of NDA Group’s US Regulatory services. Working with other NDA resources and/or outside experts, the Senior Regulatory Affairs Manager will assist with coordinating the key strategic US regulatory, drug development, pre-and post-launch for submissions (from pre-IND to NDA) to FDA.
If you have well-rounded Regulatory Affairs experience within the pharmaceutical industry dealing with pre-IND, IND and NDA submissions, this role might be for you!
- Provide project management support for approval processes that meets client’s goals
- Support Regulatory lead in identifying appropriate skills to assist with project support
- Assist Regulatory lead with preparing clients for key regulatory milestone meetings and advise on interactions with regulatory authorities. Meetings include FDA Pre-IND, EOP2, Pre-NDA, Advisory Committee, etc.
- Working with other NDA resources and/or outside experts, review key submission documents, providing meaningful strategic and content advice
- Participate in team meetings, including panels with outside external experts.
- Collaborate with the team on strategic choices involved in preparing for milestone meetings (e.g. company positions on key issues, speaker selection, integration of expert feedback).
- Participate in new client introductory calls and pitch meetings, as needed. Assist with research on potential client via press releases, Pub Med, Congress activities. Summarize relevant information for internal team.
- Work with the Regulatory lead to customize the approach to new clients based on type of company, product and project scope to build a persuasive case for NDA as the preferred partner.
- Contribute with customizing proposals and budgets to reflect specific client needs.
- Stay abreast of industry news and identify prospective clients through news feeds, publications and industry events
- Working knowledge of FDA regulations
- Preparation of regulatory documents (IND\NDA) for submission to FDA
Education / Experience / Knowledge / Skills / Abilities
- Bachelor’s degree or higher in Life Sciences
- 5-7 years in industry
- Proven track record with US regulatory processes bringing new products to market.
- Solid knowledge of Pre-IND, IND through NDA/BLA or equivalent submission requirements both with the FDA.
- Proven ability to manage and operate successfully in a collaborative, matrixed global operational structure.
- Knowledge of CTA\MAA requirements a plus