Senior Director, Regulatory Affairs - Biologics

Job Type:
Permanent
Sector:
Regulatory Affairs
Job Category:
Regulatory Executives
Region:
USA
Area:
New Jersey
Location:
Unspecified
Salary Description:
Competitive
Posted:
23/11/2016
Job Ref:
SDBMLRG

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.

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 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 mriggi@barringtonjames.com to be considered for this position!

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

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