Associate Director, Regulatory CMC

Summit Therapeutics•Palo Alto, CA

8d•Hybrid

About The Position

The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings. This role will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA. The Associate Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.

Requirements

Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science required
6 or More Years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.
Experience in biologics required
Thorough and extensive knowledge of FDA and EU regulations required
Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MAA, Amendments, Supplements etc)
A good understanding of IND, CTA, BLA and MAA
Strong computer and database skills
Attention to detail, accuracy and
Clear and concise oral and written communication skills
Excellent organizational skills
Critical thinking, problem solving, ability to work
Must be able to effectively multi-task and manage time-sensitive and highly confidential
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting
Work in a fast-paced, demanding and collaborative

Nice To Haves

Master's Degree or other advanced degree preferred
Proficiency in Mandarin Chinese (spoken and written) is highly desirable
Proficient user of standard of Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

Responsibilities

Planning, development and finalization of high-quality Regulatory CMC documents to meet global regulatory requirements.
Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development
Works closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in developing global regulatory strategies and preparing submissions for the approval for assigned products.
Manage internal review and approval process for CMC related submissions
Coordinate the planning and preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests
Manage timelines for assigned projects in alignment with company goals
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies.
RA support in interactions with Health Authorities (HA), as
Identify areas of continuous process improvement and engaging RA teams and key stakeholders as necessary.
Support in providing interpretation of global CMC regulations and guidelines, to Summit personnel for assigned programs
Provide regulatory impact assessment to CMC changes and deviations and plan, prepare and manage any related regulatory submissions as necessary.
Escalate issues that affect regulatory compliance, promptly to CMC RA Management
Maintain up to date knowledge of global regulations and guidances pertaining to CMC issues