FierceBiotech and FiercePharma Jobs
Associate Director, Regulatory Affairs Oncology - Global Recruiters of Boston North
Jan 08
Location: Northern New Jersey, Categories: Pharmaceutical
Website: http://www.grnbostonnorth.com
Position Description
Responsibilities
• 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.
Requirements
• 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.
• Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., clinical development, medical writing, medical affairs).
• 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.
