The Director/Senior Director, Regulatory Affairs CMC will act as a CMC regulatory representative to develop CMC regulatory strategies, submissions and compliance activities.
- Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products.
- Compiles, reviews and approves CMC modules of development and marketing registration applications, amendments, and supplements for submission.
- Develops and implements CMC regulatory strategies for the earliest possible product approval.
- Assists with preparation and lead meetings with Health Authorities.
- Manages and ensures compliance with all reporting requirements, including annual and periodic reports.
- Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
- Assesses and communicates CMC regulatory requirements to ensure all development activities are following applicable regulations and guidelines.
- Leads and assists in preparation of Policies, Standard Operating Procedures and Work Instructions.
- Mentors and develops regulatory talent within the regulatory department.
- Other duties as assigned.
- 10+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, Oncology experience preferred.
- Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
- Experience in working directly with key regulatory agencies (FDA, EMA) on innovative NCE and NBE.
- Demonstrated experience in CMC in bringing developmental assets to commercial stage
- Established working knowledge of regulatory guidelines and regulations (US and international).
- Regulatory experience supporting both development projects and marketed products.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Prior experience with NDA/BLA submission is strongly preferred.
Job Location: Cambridge, MA
Equal Opportunity Employer
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