Senior Director, Regulatory Affairs CMC

BeiGene, Ltd.; United States; Remote; USD 203,000 - 274,000; Full time

Job summary

An established industry player is seeking a Senior Director for Regulatory Affairs CMC to lead a dynamic team in the US. This role involves developing and executing regulatory strategies for biologics, overseeing submissions, and ensuring compliance with health authorities. The ideal candidate will have extensive experience in the pharmaceutical sector, particularly in regulatory CMC, and a strong leadership background. Join a forward-thinking organization dedicated to advancing cancer treatments and making a significant impact in the industry. This position offers the opportunity to work collaboratively in a global environment while driving excellence and innovation.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Programs

Life Insurance

Qualifications

• 15+ years in pharma/biopharma, 8+ years in regulatory CMC.
• Experience leading health authority interactions and submissions.

Responsibilities

• Lead the US biologics regulatory CMC team and develop strategies.
• Oversee regulatory submissions and health authority interactions.

Skills

Regulatory Affairs

Leadership

Pharmaceutical Development

Communication Skills

Gene/Cell Therapy

Multilingual Abilities

Education

Bachelor's Degree

Advanced Degree

Tools

Veeva Vault

Job description

Senior Director, Regulatory Affairs CMC

Senior Director, Regulatory Affairs CMC

Apply locations: Remote (US)

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: R28525

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. During this transition, "BeiGene" or "BeOne" may be used to describe the company. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

General Description:

BeiGene is seeking an experienced regulatory professional to lead the US biologics regulatory CMC team. This individual will lead the biologics regulatory CMC team based in the US, collaborate with counterparts in China, and work with cross-functional stakeholders to develop and execute biologics regulatory CMC strategies. Responsibilities include overseeing CMC-related regulatory submissions, health authority interactions, and establishing or optimizing biologics regulatory CMC processes. The individual will manage a team of 10+ and report to the global head of regulatory CMC.

Essential Functions:

• Lead, develop, and optimize the US biologics regulatory CMC team.
• Develop and implement biologics regulatory CMC strategies, authoring and managing CTD CMC sections for timely and high-quality submissions.
• Manage responses to health authority questions, prepare pre-meeting packages, and handle interactions with health authorities.
• Collaborate with cross-functional stakeholders and communicate CMC strategies for alignment.
• Oversee CMC change control assessments and ensure appropriate regulatory actions are taken.
• Lead regulatory risk assessments, identify issues, and implement mitigation activities throughout the product lifecycle.
• Establish or optimize internal SOPs, work instructions, and best practices.
• Ensure proper regulatory actions during recalls or product complaints.
• Review and approve submission documents and SOPs in the regulatory information system.
• Assess regulatory CMC aspects for due diligence projects.
• Represent the company at external activities and conferences.

Supervisory responsibilities include managing the US-based biologics regulatory CMC team of 10+ members.

Qualifications:

• Minimum 15 years in pharmaceutical/biopharmaceutical industry, including 8+ years in regulatory CMC, with a Bachelor's degree or higher.
• Proven experience in leading health authority interactions and submissions.
• Demonstrated leadership managing a team of 10+ in a global environment.
• Strong scientific background and expertise in pharmaceutical development areas.
• Experience in gene/cell therapy or medical devices is a plus.
• Deep knowledge of ICH and global regulatory CMC requirements; GMP and QA knowledge is beneficial.
• Experience in authoring complex technical documents and lifecycle management.
• Excellent communication skills; multilingual abilities are a plus.
• Strong leadership and influencing skills.
• Experience with Veeva Vault system is a plus.

Travel:

As needed

Global Competencies:

Our core values—Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit—are reflected in our twelve global competencies, including teamwork, honesty, self-awareness, inclusivity, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking, financial excellence, and clear communication.

Salary Range: $203,400 - $273,400 annually

BeiGene is committed to fair pay practices. Compensation is determined by factors such as skills, experience, education, and location. Non-Commercial roles may participate in bonuses; Commercial roles may have incentive plans. Employees can also own shares through discretionary awards and stock purchase plans. Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.

We are an equal opportunity employer and do not discriminate based on race, religion, gender, age, disability, or other protected categories. Employment decisions are based on qualifications, merit, and business needs.

About Us:

BeiGene, Ltd. plans to change its name to BeOne Medicines Ltd., pending shareholder approval, with phased implementation in 2025. During this transition, both names may be used.

BeOne is a global oncology company dedicated to developing affordable, accessible cancer treatments. We are advancing a diverse pipeline through internal and collaborative efforts. Our team of over 11,000 colleagues spans six continents. Visit www.beigene.com and follow us on LinkedIn, X, Facebook, and Instagram for more information.

For Candidates in Mainland China:

Visit the provided link for job opportunities in China Mainland.

Our Values:

At BeOne, how we work is as important as the work we do, guided by our core values that influence our decisions and actions.