Senior Manager/Associate Director, Regulatory Affairs – CMC

Senior Manager/Associate Director, Regulatory Affairs – CMC

This individual is expected to provide leadership within regulatory affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for 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. Duties and responsibilities include: the development of global CMC regulatory strategy for small molecule development products, direct management of assigned development programs, drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents), represent regulatory affairs at various project team and working group meetings, assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines, expected to develop and manage project timelines as well as have the ability to multi-task, monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic, contribute to the development of comparability protocols, validation protocols, and stability protocols, ensure the quality and content of all submissions to health authorities, liaise with partnering companies to ensure regulatory alliance, act as direct point of contact with FDA and other regulatory authorities for CMC related issues, mentor and coach junior regulatory staff and other team members. Qualifications needed are: a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful, must have a minimum of 6-8 years experience in regulatory affairs or equivalent experience within the pharmaceutical industry.  Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).  Openings in both Small Molecules and Biologics

Please refer to job code SD5593 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Boston, MA
County:	Suffolk County
ZIP Code:	02108
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856