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Associate Director of Regulatory Affairs - CMC

Location: CA
Industry: Pharmaceutical/Biotech
Job Code: 12024-12

Responsibilities:

Provide leadership within Regulatory Affairs responsible for actively contributing to the development and implementation of CMC regulatory strategy for several different therapeutic area products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA.

• Drive all CMC submission activities (IND, NDA) and health authority interactions (meeting requests and briefing documents).
• Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications. and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories.
• Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products.
• Provides strategic regulatory advice as appropriate.
• Create global strategy

Requirements:

BA/BS degree in a relevant discipline and minimum 10 years of relevant experience in Regulatory Affairs. An advanced degree is desirable. Management experience is required. Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.

Contact:

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