Shire Jobs

General Description:

• The Senior Manager, 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) through all phases of development, post-approval, and life cycle of the product depending on assigned products. Primary responsibilities will be in creating CMC regulatory strategies for development programs in preparation and maintenance of 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 marketing applications, supplements/variations, clinical trial applications 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 development programs. This includes initial submission of INDs, CTAs, and 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 clinical trials and 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 subteams.

• 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.

Core Competencies, Knowledge and Skill Requirements

• Expertise in development and commercial product lifecycle (Phase 1-3, 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 IND, CTA, BLA and MAA processes.

• Strong 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 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.

Communication & Interpersonal Skills •

• Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.

• Proven ability to build trust and respect within the organization.

Significant Contacts

• Interacts with BeiGene employees and senior management.

• Interacts with external business partners and Regulatory Agencies.

Qualifications:

Education:

• 7+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+ years of experience with a higher-level degree.

Experience:

• Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products).

Supervisory Responsibilities:

• Not currently

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.