Senior Manager, Regulatory CMC (Small Molecule)

BeiGene, Ltd.

Job Overview

Location

Remote (US)

Job Type

Full-time

Full Job Description

📋 Description

• Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications.
• Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Health Authorities as needed for the assigned project.
• Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects.
• Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely.
• Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions.
• Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project.
• Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project.
• Provide comments on new global guidance through company’s commenting process.
• The position may or may not manage direct report(s).
• BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

🎯 Requirements

• 7+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
• BA/BS Degree in scientific disciplines, MS/PhD preferred.
• A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries.
• In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.
• Demonstrated leadership as a people manager.
• Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management.
• 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, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
• Microsoft 360, Familiarity with Veeva is a plus.

🏖️ Benefits

• Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan.
• Eligibility to participate in the annual bonus plan (Non-Commercial roles) or incentive compensation plan (Commercial roles).
• Commitment to fair and equitable compensation practices with salary range of $135,200.00 - $180,200.00 annually.
• Support for reasonable accommodation in the job application process for individuals protected by applicable federal, state or local laws.
• Equal opportunity employer committed to diversity and inclusion.

Skills & Technologies

REST

Senior

Remote

Degree Required

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BeiGene, Ltd.

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About BeiGene, Ltd.

BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.

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