Manager, Regulatory CMC

Role Summary

The Manager, Regulatory Affairs CMC, is responsible for coordination and preparation of Chemistry, Manufacturing and Controls (CMC) regulatory submissions 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 on-going clinical activities as well as marketing applications.

Responsibilities

• Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings and acts independently to identify and resolve problems
• Manage CMC regulatory filings in US and ex-US clinical and marketing applications
• 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 appropriate
• 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 guidance pertaining to CMC issues
• All other duties as assigned

Qualifications

• Required: Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science; Master's Degree or other advanced degree preferred
• Required: A minimum of 3+ 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.)
• Required: A good understanding of IND, CTA, BLA and MAA processes
• Preferred: Proficiency in Mandarin Chinese (spoken and written)
• Preferred: Proficient user of Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools
• Required: Strong computer and database skills
• Required: Attention to detail, accuracy and confidentiality
• Required: Clear and concise oral and written communication skills
• Required: Excellent organizational skills
• Required: Critical thinking, problem solving, ability to work independently
• Required: Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Required: Communicate effectively and articulate complex ideas in an easily understandable way
• Required: Prioritize conflicting demands
• Required: Work in a fast-paced, demanding and collaborative environment

Skills

• Proficiency with standard office software (Word, Excel)
• Experience using electronic document management systems and document review tools
• Strong computer and database skills
• Clear and concise oral and written communication
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently
• Ability to multi-task and manage time-sensitive, confidential documents
• Ability to communicate complex ideas clearly and prioritize conflicting demands
• Willingness to work in a fast-paced, collaborative environment
• Mandarin Chinese language skills (preferred)

Education

• Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science required; Master's Degree or other advanced degree preferred