The Executive Director, CMC Regulatory Affairs, will be responsible for and providing leadership in all Regulatory Affairs functions relating to Technical, Manufacturing and Quality Operations for development and marketed products. The position will involve writing, reviewing and filing regulatory submissions and have a key role in relevant communications and meetings with Regulatory Authorities.
This position in the Regulatory Affairs group will be responsible for providing Regulatory CMC leadership for projects at various stages of development for all products in our portfolio.
Responsibilities will include:
- Lead regulatory coverage and oversight in all CMC submissions (including clinical trial, marketing and post-marketing applications, routine reports/renewals) and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures, with the goal of obtaining the earliest possible product approvals.
- Maintain up-to-date knowledge of regional and global regulatory CMC requirements, analyze current trends and anticipate changes in the Regulatory requirements to adjust CMC strategic plans accordingly.
- Provide training for stakeholders on current and new Regulatory CMC requirements to ensure company-wide compliance.
- Write and review dossiers and technical documents for submissions and recommend changes as appropriate to ensure approval and/or compliance with existing regulatory approvals.
- Provide regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department, including supporting preparation for facility inspections of vendor sites by health authorities when necessary.
- Assist with managing regulatory agency interactions, document preparation, co-ordination of meeting rehearsals and minutes with a sense of urgency.
- Articulate complex Regulatory CMC issues and act as a liaison between Technical Operations and Regulatory Affairs.
- Contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs.
- Manage relationships with key stakeholders in Technical Operations and Quality and across Regulatory Affairs to provide CMC regulatory support in achieving strategic objectives.
- Work effectively with Regulatory stakeholders in addressing GMP issues.
- Create and maintain Regulatory CMC development plans that are aligned with product development plans.
- Assist in Regulatory due diligence and acquisition transfer activities.
- Initiate local process improvement and contribute to local and/or global process improvements which have significant impact for the Regulatory Affairs Department or other departments.
- The position is responsible for handling multiple projects with competing priorities.
- Other duties as assigned.
- BS in relevant scientific discipline. An advanced degree is desirable, certification in Regulatory Affairs is a plus.
- 12+ years of pharmaceutical industry experience
- 8+ years of experience working in regulatory affairs CMC
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in leading CMC submission preparation and Health Authority interactions
- Previous experience working in a fast-paced environment on multiple product lines a plus.
- Solid understanding of FDA regulations, dossier preparations by eCTD organization and GMPs requirements on drugs and devices in both development and commercial stage products.
- Good expertise on Regulatory CMC, exposure to international Regulatory CMC is a plus.
- Experience in regulatory assessments of post-marketing manufacturing changes and in preparing technical portion of INDs, NDAs, amendments and supplements.
- Strong organizational and program management skills to maintain high level productivity, innovation and priority setting, completing assignments on time and on budget.
- Strong problem solving and diplomacy skills required.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
Job Location: Cambridge, MA
Please send resumes to email@example.com
Equal Opportunity Employer
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