Associate Director, CMC Regulatory

The Opportunity:

As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed’s pipeline compounds/products.

This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed’s global clinical trials, including programs executed in collaboration with external partners, marketing applications, and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements and be able to guide CMC teams throughout the drug development process.

Primary Responsibilities:

• Develop, lead, and implement global CMC regulatory strategies to support clinical development through registration and post-marketing activities.

• Provide CMC regulatory leadership for global clinical trial execution, including RevMed‑sponsored trials and incoming/outgoing external collaborations, ensuring appropriate CMC strategy, documentation, cross‑referencing, and health authority compliance across sponsors, regions, and development stages.

• Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.

• Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met.

• Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify. regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.

• Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.

• Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed’s products.

• Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Required Skills, Experience and Education:

• BA/BS degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.

• Minimum of 10 years of experience in pharmaceutical/biotech drug development, including at least 5 years in global CMC regulatory affairs.

• Experience in leading CMC related global clinical and commercial submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).

• Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.

• Demonstrated experience in effective collaboration with internal and external stakeholders.

• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

Preferred Skills:

• An advanced degree (PhD, PharmD, MSc) in Pharmaceutical Science, Chemistry, Chemical Engineering or related field is desirable. #LI-Hybrid #LI-CT1