Senior Director, Regulatory CMC

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.

Role and Responsibilities

1. 1Develop CMC regulatory strategies for biologics at all stages of development from early Phase through marketing applications and post-approval changes.

1. 2Accountable for providing high level strategic and operational regulatory direction on regulatory CMC issues globally.

1. 3Accountable for leadership in strategic regulatory development plans and risk assessments, critical issue management and advice on Health Authority interactions.

1. 4Responsible for ensuring the appropriate execution of all regulatory CMC strategies.

1. 5Lead CMC content authoring, review, and approval of regulatory submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses to health authority questions

1. 6Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness

1. 7Serve as Senior CMC regulatory lead on interactions with health authorities including leading the planning and preparation for Meetings with Health Authorities

1. 8Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies

1. 9Provide regulatory oversight for post-approval CMC submissions, ensuring consistency with approved dossiers and global regulatory requirements

1. 10Serve as the Regulatory CMC subject matter expert on cross-functional teams

1. 11Manage regulatory CMC aspects of relationships with collaborators and external manufacturing partners

1. 12Work closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in the implementation of Regulatory Strategies to meet the Company Goals

1. 13Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.

1. 14Contribute to and help scale regulatory CMC processes, tools, and templates

1. 15Ensure compliance of Summit Programs with global CMC regulations and guidelines

1. 16Maintain current knowledge of global CMC regulations and guidance

1. 17Mentor and Develop CMC Regulatory Talent and help in building a high-functioning Reg CMC Team

1. 18All other duties as assigned.