FierceBiotech and FiercePharma Jobs
Senior Director, Regulatory Affairs - Pharma Search
Jun 19
Location: Orange, New JerseyCategories: Pharmaceutical
Position Description
Senior Director, Regulatory Affairs Oncology- Strong Biologics (Northern N.J.)
Senior Director, Regulatory Affairs Oncology This has been upgraded to a Senior Director that must have significant Biologics and BLA background
My name is Volora Howell, I am a sr. recruiter for Pharma Search, my client is based in Northern NJ is seeking an experience Senior RA Director
with Oncology Drug experience with a heavy BLA /Biologics background.
Relo assistance is provided
Up to 200K base LTI 140K 20% bonus
Department Name : Regulatory Affairs
Location/Territory Name : Northern , NJ
Job Description : The incumbent is responsible for but not limited to the following:
Develop and guide the regulatory strategy ! for the approval of assigned Oncology products.
Aid and supervise the preparation of regulatory submissions in the US, Canada, and Latin America.
Serve as the Regulatory International Product Team (IPT) member for Oncology and provide regulatory leadership.
Monitor Oncology programs so they comply with the required Health Authority Regulations and Laws.
Interact with Health Authorities to address regulatory issues and to maintain the product development plan on schedule.
Coordinate regulatory project activities with global counterparts.
Job Qualifications : BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology, Pharmacology, Pharmacy or Nursing). PhD, PharmD, or comparable degree in the life sciences highly desired.
Sr. RA Director: Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., clinical development, medical writing, medical affair! s).
Must have experience in interacting with the appropriate regulatory bodies and in Oncology Drug Development.
Must possess in-depth knowledge of appropriate Code of Federal Regulations, Regulatory Guidance Documents and ICH Regulations.
Experience with electronic submissions highly desirable and having completed filings (i.e., NDA’s, BLA’s, IND’s) to health authorities.
History of working in complex team environments with numerous/diverse stakeholders. —-—-—-—-—-—-——-
