Senior Director, Regulatory CMC

Overview of Role:

The Senior Director, Regulatory Affairs, CMC, is responsible for developing Regulatory Strategies and Submissions for Summit products globally. This role will provide regulatory strategy leadership, for development, commercialization and life cycle management of Summit products.

The Senior Director will work in close collaboration with cross functional teams including Manufacturing, Analytical, Supply Chain and Quality to develop regulatory strategies aligned with company goals. The Senior Director will bring hands on experience leading regulatory CMC programs in biologics and demonstrated leadership skills. This role is both strategic and hands-on and will be responsible for all the regulatory CMC activities.

Role and Responsibilities:

• Develop CMC regulatory strategies for biologics at all stages of development from early Phase through marketing applications and post-approval changes.

• Accountable for providing high level strategic and operational regulatory direction on regulatory CMC issues globally.

• Accountable for leadership in strategic regulatory development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Responsible for ensuring the appropriate execution of all regulatory CMC strategies.

• Lead CMC content authoring, review, and approval of regulatory submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses to health authority questions

• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness

• Serve as Senior CMC regulatory lead on interactions with health authorities including leading the planning and preparation for Meetings with Health Authorities

• Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies

• Provide regulatory oversight for post-approval CMC submissions, ensuring consistency with approved dossiers and global regulatory requirements

• Serve as the Regulatory CMC subject matter expert on cross-functional teams

• Manage regulatory CMC aspects of relationships with collaborators and external manufacturing partners

• Work closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in the implementation of Regulatory Strategies to meet the Company Goals

• Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.

• Contribute to and help scale regulatory CMC processes, tools, and templates

• Ensure compliance of Summit Programs with global CMC regulations and guidelines

• Maintain current knowledge of global CMC regulations and guidance

• Mentor and Develop CMC Regulatory Talent and help in building a high-functioning Reg CMC Team

• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required and Master's Degree or other advanced degree (Ph.D, PharmD) preferred

• 15 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 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.