Associate Director, CMC Dossier Strategy & Leadership
About The Position
Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-functional teams of internal and external subject matter experts. Ensures consistent preparation of CMC regulatory submission documents that are scientifically and technically strong and compliant with global regulatory requirements. Implements efficient processes for preparing, reviewing, and approving CMC sections. Ensures the CMC submission strategy aligns with clinical and regulatory development strategy, and provides drug development expertise and advice to the CMC team. Influences the development of regulatory guidance and ensures timely assessment and implementation of new requirements. Leads CMC coordination for later-stage and more complex projects, anticipates regulatory questions, and helps drive first-pass approvals. The role manages CMC submission documentation across multiple projects using matrix management, serves as the primary Dossier Strategy & Leadership representative to CMC Regulatory, and develops processes, tools, and templates for submission planning and dossier preparation. It partners with CMC Regulatory to identify submission risks and mitigation strategies, coordinates authors and reviewers across internal groups, and represents CMC teams in communications with DSL management. The position may mentor or supervise dossier authors.
Requirements
- Bachelor’s degree and at least 8–10 years of CMC experience required.
- Interdisciplinary experience required.
- Excellent scientific writing skills, including contributions to INDs and/or marketing applications, and knowledge of regulatory requirements.
- Strong written and verbal communication skills, including the ability to summarize and communicate findings promptly and efficiently.
- Ability to make decisions based on scientific data, manage and prioritize multiple projects simultaneously, and work with a sense of urgency.
- Demonstrated negotiation, influencing, and leadership skills.
- Ability to develop relationships with external collaboration partners and internal stakeholders.
Nice To Haves
- Master’s degree with at least 6–8 years of CMC experience preferred.
- PhD degree with at least 4–6 years of CMC experience highly preferred.
- Biologics experience strongly preferred.
Responsibilities
- Author and coordinate submission documentation for all phases of biologics clinical development, emphasizing later-phase programs and marketing applications, often under significant time pressure.
- Drive team resolution of regulatory authority questions and author responses.
- Lead global cross-functional CMC teams in completing global regulatory submission documents, applying biologics drug development experience and awareness of global pharmaceutical development requirements.
- Ensure regulatory changes are implemented in local practices and procedures.
- Manage completion of CMC regulatory submission documentation for multiple projects of moderate complexity using a matrix management approach.
- Serve as the primary Dossier Strategy & Leadership representative interfacing with the CMC Regulatory group.
- Develop standard processes and lead CMC project teams in planning, preparing, reviewing, and approving CMC submission sections.
- Develop and maintain CMC regulatory document templates in collaboration with CMC Regulatory and Process R&D.
- Partner with CMC Regulatory to identify submission-related risks and develop mitigation strategies.
- Review regulatory guidance and maintain expertise and organizational memory of regulatory issues.
- Coordinate document authoring and reviews with groups outside DPD, including Process R&D Operations S&T, preclinical safety, PK, and QA.
- Interface with CMC Regulatory personnel to ensure consistency across projects and communicate issues to DSL management on behalf of the CMC team.
- Develop and maintain tools and templates and lead cross-functional initiatives to streamline regulatory submission dossier preparation.
- Facilitate the establishment of high-performing teams.
- May mentor or supervise dossier authors and guide and evaluate their performance.
Benefits
- Paid time off, including vacation, holidays, and sick time
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Eligibility to participate in long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
