23 days ago
The Associate Director, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) with emphasis on marketed products, including post-approval changes, and life cycle management for the assigned products. Primary responsibilities will be in creating CMC regulatory strategies for commercial programs in preparation and maintenance of marketed regulatory applications.
Essential Functions of the Job:
- Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
- Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
- Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product.
- Manage/prepare CMC document packages for regulatory submissions in support of the commercial program. This includes initial BLA/MAA submission, amendments to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
- Manage timelines in cooperation with Project Management on assigned projects.
- Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions to support marketing applications, and their amendments in conformance with regulatory requirements, strategies, and commitments.
- Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
- Actively participate as a member of global regulatory teams and CMC sub-teams.
- Support and manages regulatory aspects of CMC Operations including authoring, reviewing and and/or approving SOP’s, CAPA’s, etc. •
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
- Other duties as assigned.
Minimum 8 years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in product life cycle for marketed products.
- Expertise in commercial product lifecycle (Marketed products).
- Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required, global submission experience desired.
- A good understanding or BLA, post approval changes, and MAA processes.
- Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to marketed product regulatory issues.
- Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
- Demonstrated ability to coach, train and mentor teams.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Ability to prioritize and handle multiple projects simultaneously.
Education Required: Bachelor of Science degree, in a related scientific discipline
Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), Veeva Data Management System
Travel for Work: Must be willing to travel approximately 10-25%