Senior Director, Regulatory Affairs - CMC

Job Type:
Regulatory Affairs
Job Category:
Regulatory Executives
New Jersey
Salary Description:
Job Ref:

The Senior Director, Regulatory Affairs - CMC 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 CMC 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.

Job responsibilities:

  • 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 CMC. 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 Project Management 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 CMC activity 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 CMC (with an emphasis on the therapeutic areas of oncology, respiratory, and/or immunology). An advanced degree (Master’s or PhD) is also preferred.

Please contact Melissa Riggi at 212-719-7526 or to be considered for this position!

Contact Details:
Tel: 212-719-7526
Contact: Melissa Riggi

You may return to your current search results by clicking here.

Latest Job Listings