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Director Regulatory Affairs CMC

Company: AGTC
Location: Cambridge
Posted on: May 12, 2022

Job Description:

The Director, Regulatory Affairs CMC is responsible for ensuring company chemistry, manufacturing, and control (CMC) strategies are developed and executed in compliance with established regulations, guidelines, and industry standards.

Reporting Relationship
The Director, Regulatory Affairs CMC will report to the SVP, Regulatory Affairs, or designee

Duties and Responsibilities
Responsible for regulatory strategy regarding the Chemistry, Manufacturing and Control (CMC) of AGTC's products, participating in the development and implementation of regulatory strategies for AGTC's therapeutic programs from candidate selection through post-marketing support.
Leads cross-functional team in developing, implementing, and updating CMC strategies and activities associated with AGTC's therapeutic programs.
Conducts regulatory risk assessments and recommends developmental options
Provide mentoring and management of junior team members.
Leads project management of and technical team in development of global CMC regulatory submissions, including clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., BLA and MAA).
Drives decision making and the associated deliverables across all functions on the CMC RA Team.
Serves as RA CMC representative expert during cross functional initiatives and workstreams.
Leads preparation, review, and assembly of CMC documentation for Regulatory Authority submissions (including routine correspondence, INDs, IMPDs, BLAs, MAAs, Annual Reports, Amendments, Supplements, briefing packages, Orphan Drug Applications, etc.) with minimal oversight
Responsible for CMC change management evaluation for AGTC's products and for providing guidance to inter-disciplinary project teams on product manufacturing and development approaches and regulatory submission requirements
For assigned projects, leads all aspects of CMC health authority meetings; identifying critical issues with the development team for discussion with health authorities, leads preparation of briefing books; prepares development team members (as applicable) for the meeting and leads the preparation and finalization of meeting minutes as relates to RA CMC
Liaise with regulatory authorities as needed to further product development programs and keep them in good standing
Maintains an expertise and keeps current in areas focusing on gene therapy CMC requirements
Continue professional development by attending regulatory CMC-related meetings applicable to gene therapy products
Assist in the maintenance of corporate quality systems in line with current GxP standards, regulations, and company directives
Aid in the implementation of infrastructure necessary for successful completion of product development (e.g., preparation of written procedures, review of departmental SOPs, establishment of electronic document standards)
Other duties as assigned
This job description is subject to change at any time.

Educational Qualifications
BS degree in a scientific discipline
MS or PhD preferred

Additional Qualifications
At least eleven (11) years' experience in Regulatory Affairs
At least ten (10) years' experience supporting the manufacture and control of biologic drug products
- Direct experience in preparation, management, and review of regulatory applications in eCTD format. Hands-on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions.
Knowledge/experience in Quality Assurance and GMP regulations.
In-depth knowledge of ICH requirements and global regulatory CMC requirements.
Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidance, accelerated regulatory review paths, and policy trends.
Strong interpersonal, negotiating, and problem-solving skills
- Excellent verbal and written communication skills in highly complex technical areas.
Strong project management and organizational skills with ability to multi-task on several projects

Keywords: AGTC, Cambridge , Director Regulatory Affairs CMC, Executive , Cambridge, Massachusetts

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