Manager, Regulatory Affairs

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

My client is actively hiring generics experts to build out their regulatory affairs team. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!

The Regulatory Affairs Manager will oversee and guide Associates and/or Senior Associates in planning, authoring, compiling, and submitting regulatory submissions to the FDA.  This person will play a key role in guaranteeing consistency, both internally and in relation to FDA guidelines, by planning, organizing, composing, and reviewing all submissions. 

The ideal candidate will come from a strong generics background and possess substantial interpersonal skills  to help navigate challenges faced by a rapidly growing company.

Job responsibilities:

  • Arrange and assemble new ANDAs, Amendments, Supplements, Annual Reports, and 505(b)(2) and 505(b)(1) filings.
  • Rigorously review all documents intended to be submitted to the FDA.
  • Lead, mentor, and motivate a team of 1 to 3 direct reports.
  • Establish project plan due dates and monitor change management activities to ensure timely execution. 
  • Act as the regulatory representative to obtain documentation from team members and department representatives.

Job-specific skills:

  • In-depth knowledge and understanding of FDA guidelines with demonstrated success working in a generics pharmaceutical environment.
  • Ability to effectively prioritize tasks in a fast-paced, small company environment.
  • Effective communication and leadership skills, as well as the ability to analyze and determine the impact of regulatory complications.

A Bachelor's degree in a life science field is required, as well as at least 7 years in the pharmaceutical industry with a minimum 5 of those years in  regulatory affairs (with an emphasis in generics) and at least 2 years of supervisory experience. An advanced degree is also preferred.

Please contact Melissa Riggi at 212-719-7526 or email your CV to mriggi@barringtonjames.com to be considered for this position!

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

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