My client in New Jersey is actively hiring Biologics experts to lead their Regulatory Affairs team. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!
The Senior Director, Regulatory Affairs - Biologics will function as the representative for a multitude of new projects with a focus on oncology, autoimmune diseases, and the respiratory therapeutic area. This person will play a key role in facilitating global registration and product development as a spokesperson throughout communication with regulatory agencies.
The ideal candidate will come from a strong Biologics background with the ability to mentor and lead teams, as well as possess substantial interpersonal skills to help navigate challenges faced by a rapidly growing company.
- Cultivate and carry out new regulatory strategies for projects to contribute to expeditious development and timely registration.
- Plan, author, and review sections of all regulatory submissions with high regards to the Biologics area. Documents include but are not limited to INDs, NDAs, CTAs, MAAs, meeting requests, and briefing documents.
- Lead, mentor, and motivate a team as the lead representative for Regulatory Affairs on the Product Development Team and the Global Regulatory Functional Team.
- Rigorously review all documents intended for submission to the FDA.
- Establish project plan due dates and monitor change management activities to ensure timely execution.
Job Specific Skills:
- In-depth knowledge and understanding of FDA guidelines, specifically in relation to the development and registration of biological drug products.
- Effective communication and leadership skills, as well as the ability to analyze and determine the impact of regulatory complications.
- Experience with IND and NDA filings, as well as experience contacting and organizing meetings with the FDA.
Of course a raise in salary is always an added bonus, but the real driver for you will be the benefits of joining my client’s team!
- Be a leading representative for a fast-paced team within a cross-functional setting.
- Act as a coordinator for all Regulatory activity pertaining the Biologics area, both internally and externally within a deadline structure borne of your own influence.
- Work in a challenging environment where the most notable feature is consistent employee satisfaction and growth.
- Build and mentor your own team, and have the opportunity to build upon your extensive background for even further professional advancement.
A Bachelor's degree is required, as well as at least 12 years in regulatory affairs with at least 8 of those years in the Biologics therapeutic area, preferably CMC. An advanced degree (Master’s or PhD) is also preferred.
Please contact Melissa Riggi at 212-719-7526 or email@example.com to be considered for this position!