Director Regulatory Affairs CMC
Company: AGTC
Location: Cambridge
Posted on: May 12, 2022
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Job Description:
Mission
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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