Director/Sr Director, Regulatory Affairs CMC
Company: Sumitomo Dainippon Pharma Oncology
Posted on: January 12, 2022
Director/Sr Director, Regulatory Affairs CMC The Senior
Director, Regulatory Affairs CMC will act as a CMC regulatory
representative to develop CMC regulatory strategies, submissions
and compliance activities. Responsibilities
- 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
- Develops and implements CMC regulatory strategies for the
earliest possible product approval.
- Assists with preparation and lead meetings with Health
- 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
- Leads and assists in the preparation of Policies, Standard
Operating Procedures and Work Instructions.
- Mentors and develops regulatory talent within the regulatory
- Other duties as assigned. Qualifications
- 10+ years of experience in Regulatory Affairs related to the
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
- 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
- Strong knowledge of eCTD elements and structure and regulatory
- Prior experience with NDA/BLA submission is strongly preferred.
Dedicated to the Promise of Purposeful Science At Sumitomo
Dainippon Pharma Oncology, we are advancing meaningful therapeutic
options for patients with cancer. Through scientific persistence
and a commitment to discovery, we are focused on pursuing a diverse
and purposeful pipeline.
Learn more about our pipeline . Privacy Notice Sumitomo Dainippon
Pharma Oncology is a registered trademark of Sumitomo Dainippon
Pharma Co., Ltd.
Keywords: Sumitomo Dainippon Pharma Oncology, Cambridge , Director/Sr Director, Regulatory Affairs CMC, Executive , Cambridge, Massachusetts
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