Associate Director, Regulatory CMC (Small Molecule)

BeiGene

36d • $142,000 - $192,000

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines for the assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics.

Requirements

• 8+ 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.
• 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.

Nice To Haves

• Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.

Responsibilities

• 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 Heath 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level