Director, Regulatory Affairs CMC

Overview of Role:

The 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 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.

Role and Responsibilities:

• Develop and execute CMC regulatory strategies for Clinical Phase and Commercial Development as life cycle management.
• Manages the preparation of high quality Regulatory CMC submissions including, IND, IMPD, BLA, MAA and post approval supplements as needed to meet global regulatory requirements.
• Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development
• Work closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in the implementation of Regulatory Strategies to meet the Company Goals
• Plan and participate in the preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests
• Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies.
• Lead and participate in Regulatory interactions with Health Authorities (HA), as appropriate.
• Develop Regulatory CMC strategies and Risk assessments for assigned projects.
• Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.
• Support in providing interpretation of global CMC regulations and guidelines, to Summit personnel for assigned programs
• Provide support during Health Authority inspections 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

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required. Master's Degree or other advanced degree preferred
• 10 or more years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.
• Experience in biologics required
• Thorough and extensive knowledge of FDA, EU and global regulations required
• Significant experience in developing regulatory strategy for complex products and experience in the preparation of CMC sections for complex regulatory submissions Excellent understanding of IND, CTA, BLA and MAA processes.
• Experience in engaging with health authorities on regulatory CMC topics
• 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
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality.
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment.