The Director of Regulatory Affairs CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds through all phases of development, post-approval, and life-cycle of the product.
Provides support for all phases of the product development in the assigned portfolio and interfaces with R&D, Project Management, Process Sciences, Manufacturing, Supply Chain, Quality, and Regulatory colleagues, as well as third party laboratories and contract manufacturers.
Develops effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and is able to interpret and apply local regulations and guidance’s to the life cycle of a drug product. This includes review of changes in existing products to determine the need for new/revised submissions or document reason(s) why submission of the change is unnecessary.
Oversees/prepares CMC document packages for regulatory submissions. This includes initial submission to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
Manages timelines in cooperation with Project Management on assigned projects.
Authors/reviews CMC sections of IND, CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
Uses extensive knowledge of US, EU and ICH CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
Ability to work with regulatory CROs to identify regional/country-specific CMC requirements to support global marketing applications.
Manages post-approval CMC compliance with marketed drugs in all regions/countries where the drug is registered.
Supports and manages regulatory aspects of CMC Operations. Performs regulatory review, assessment, and approval of change controls, SOP’s, CAPA’s, etc.
Experience and Background:
BS/BA Biochemistry, Biology, or Pharmaceutical Science. Advanced degree preferred (e.g., PhD, PharmD) with at least 8-10 years experience in the pharmaceutical industry and at least 5 of these years in a Regulatory CMC function with biological products. Global responsibilities preferred.
Biologics experience required.
Demonstrated successful regulatory agency (FDA-CBER, EMA, etc.) interactions.
Preferred candidates will have experience working as a lead in Regulatory Affairs CMC across two or more major geographic areas.
Has scientific understanding of drug development for recombinant biological products.
Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally, demonstrated success in negotiation skills, strategic thinking, strong verbal and written communication, leadership and be a credible business partner within the organization.
Demonstrated ability to author CMC/Quality sections of biologics regulatory submissions.
Knowledge of Quality-by-Design principles and application for biological processes preferred.
Demonstrated experience with Regulatory Affairs aspects of CMC Operations support.
State or Province