Senior Director Regulatory Affairs ? Help
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Specific Responsibilities
* Provides Strategic Regulatory input into Clinical development programs, Phase IIIb –IV and LCM activities
* Provides Strategic and Operational oversight to Regulatory CMC activities
* Provides Strategic Regulatory input for all interactions with state and federal Regulatory agencies, as needed
* Oversee operations of the Regulatory Affairs department
* Provides regulatory tactics to maintain existing products in compliance with applicable regulations
* Provides regulatory input and oversight for promotion and advertising materials for prescription drugs, OTC monographed products and dietary supplements
* Develops regulatory strategies to develop and obtain approval of new products
* Ensures department operations conform to SOPs and applicable regulations and guidelines, e.g., 21CFR 201, 202, 312, and 314
* Responsible for all interactions with regulatory authorities, e.g., FDA
* Supervises department employees (6 direct reports) and provides training on policies and procedures, and regulations and guidelines, both existing and emerging
* Responsible for budget oversight
* Identifies resource and skill gaps and recruits staff as required
* Provides Regulatory input in to Business Development activities and leads the Regulatory component of PTRS assessments
Special Qualifications and Experience Desired
· Minimum of 10-15 years of experience in the Pharmaceutical or Biotechnology industry and atleast7 years of increasingly responsible positions in Regulatory Affairs
·
· RAC ( Regulatory Affairs Certification) preferred
· A candidate should have scientific education and degree. Scientific education and degree, preference to graduate degrees, e.g., Ph.D., Pharm.D., M.S., etc.
· Must have experience with developing and obtaining approval of new products, as well as supporting marketed products, including advertising and promotion review
· Must have led Regulatory strategy activities including, FDA interactions including but not limited to: Type A, Type C and SPA requests and meetings
· Must have experience interacting and interfacing with Regulatory agencies
· Must have experience with Due diligence activities including but not limited to :
review of Regulatory CMC documents
· IND filings, updates, cross referencing
· NDA filings, updates, cross referencing
· sNDA,aNDA filings, updates, referencing
· Exclusivity regulations
· Orphan Drug regulations
· Must have had management experience, including direct supervision of staff
· Experience interacting with senior management of company
· Must be able to combine scientific qualities with business acumen to assist in meeting company objectives
* Meda Pharmaceuticals Inc. is an Equal Opportunity and Affirmative Action Employer *
