Ra Sr. Mgr. - CMC - regulatory Affairs - Pharm
MA
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
812
Opportunity Description:
( 617) Area Code Mass.
Sr. Manager of CMC / Regulatory Affairs
This individual is responsible for actively contributing to the development and implementation of CMC regulatory strategy for small molecule 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 the FDA.
Duties;
Contribute to the development of global CMC regulatory strategy for products in development.
Direct management of assigned small molecule 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.
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 equivalency 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.
Mentor and coach junior regulatory staff and other team members.
Basic Qualifications: Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 4 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.
Preferred Qualifications: Must demonstrate a solid working knowledge of drug development process and knowledge of US 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).
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