BeiGene · 3 days ago

Senior Manager, Regulatory Affairs, CMC

United States

Full-time

Remote

Senior Level

$133K/yr - $178K/yr

7+ years exp

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BiotechnologyHealth Care

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Responsibilities

Develop and implement small molecule regulatory CMC strategies as well as author CTD CMC sections for assigned projects to ensure on-time and high-quality global submissions for investigational, marketing, and post-approval applications.

Develop regulatory strategy and execute the preparation of timely responses to small molecule regulatory CMC questions, pre-meeting packages, and interactions with Heath Authorities as needed for assigned projects.

Work collaboratively with cross-functional leads and communicate regulatory CMC strategies for assigned projects.

Lead regulatory risk assessment, identify key regulatory CMC issues and mitigation activities needed throughout product life cycle. Escalate critical issues to senior management.

Lead or contribute to development of internal regulatory CMC guidance, SOPs, and work instructions.

Ensure proper regulatory CMC assessments and actions are taken when recalls or product complaints arise during product lifecycle for assigned projects.

Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for assigned projects.

Provide comments on new global guidance through company’s commenting process.

Qualification

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Regulatory CMC experienceGlobal submissionsICH requirements knowledgePharmaceutical development expertiseTechnical document authoringMicrosoft 360

Required

7+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience with proven record of experience in global submissions for clinical trial/marketing applications and subsequent response to HA queries.

BA/BS degree in scientific discipline.

In-depth knowledge of ICH requirements and US/EU regulatory requirements.

Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.).

Excellent oral and written communications skills are a must-have.

The candidate should be detail-oriented, self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.