Senior Director, Regulatory Affairs CMC

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

Job summary

A global oncology company is seeking a Senior Director of Regulatory Affairs CMC who will lead the U.S. biologics regulatory team and develop CMC strategies. The ideal candidate will have extensive experience in regulatory affairs, team management, and a solid understanding of biopharmaceutical CMC processes. This remote position offers a competitive salary and comprehensive benefits package.

Benefits

Medical Insurance

401(k) Plan

Paid Time Off

Wellness Programs

Qualifications

• Minimum 15 years of experience in pharmaceutical or biopharmaceutical industry.
• 8 years of regulatory CMC experience required.
• Experience managing a team of 10+ in a global environment.

Responsibilities

• Lead and optimize the US biologics regulatory CMC team.
• Oversee regulatory submissions and interactions with health authorities.
• Develop and implement CMC regulatory strategies.

Skills

Leadership

Communication

Problem Solving

Regulatory Knowledge

Education

Bachelor's Degree in Science or related field

Tools

Microsoft 360

Veeva Vault

Job description

Senior Director, Regulatory Affairs CMC page is loaded

Senior Director, Regulatory Affairs CMC

Apply locations Remote (US) time type Full time posted on Posted 6 Days Ago job requisition id R28525

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:
BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based in US, partners with the counter-part based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and health authority interactions throughout the product lifecycle. The individual also leads the team to establish or/and optimize biologics regulatory CMC processes. The individual manages direct reports of 10+ and reports to global head of regulatory CMC.

Essential Functions of the job:
• Lead, develop, and optimize the current biologics regulatory CMC team in US.
• Lead or/and oversee the development and implementation of biologics regulatory CMC strategies as well as lead the team authoring and managing CTD CMC sections to ensure on-time and high-quality submissions for investigational, marketing, and post-approval applications.
• Lead or/and oversee the development and implementation of biologics regulatory CMC strategy and execution in the preparation of timely responses to HA CMC questions, pre-meeting packages, and interactions with Heath Authorities.
• Work collaboratively with cross-functional stakeholders and communicate biologics regulatory CMC overarching strategies for alignment,
• Lead or/and oversee biologics CMC change control regulatory CMC impact assessment and ensure right regulatory CMC actions are taken timely.
• Lead or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product lifecycle. Escalate the critical issues to senior management timely.
• Lead or/and oversee the establishment or/and optimization of internal regulatory CMC SOP, working instructions, and best practice, etc.
• Ensure proper regulatory CMC assessment and actions are taken when recalls or product complaints arise during product lifecycle.
• Review and approve regulatory CMC submission documents, SOPs/WIs, etc. in regulatory information system (RIM).
• Oversee or lead the assessment regulatory CMC aspects for due diligence projects.
• Lead or participate in external activities/conferences representing the company or the department when needed.
Supervisory Responsibilities:
Manage existing US based biologics regulatory CMC team of 10+ members.

Computer Skills:
Microsoft 360

Other Qualifications:
• Minimum 15 years of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development, manufacturing, Quality, etc. including minimum 8 years of regulatory CMC experience with a Bachelor's Degree required.
• A proven record of leading Health Authority interactions, CTA, BLA/ submission, and subsequent response to HA queries.
• Demonstrated leadership of managing a team of 10+ people in global working environment is a must-have.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (upstream, downstream, formulation, analytical, manufacturing, QC, QA, etc.).
• Experience in gene/cell therapy or/and medical device is a plus.
• In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP regulation is a plus.
• Experience in authoring complex technical documents, CTD M2 and M3 sections, and their lifecycle management.
• Excellent oral and written communications skills are a must-have. Multilingual is a plus.
• Excellent interpersonal, communication, and problem-solving skills.
• Strong ability to effectively lead and influence in the collaborative and fast-moving work environment.
• Experience of using Veeva Vault system is a plus.

Travel:
As needed

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $203,400.00 - $273,400.00 annually

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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. 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.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail] .

About Us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more aboutBeOne, please visitwww.beigene.com and follow us onLinkedIn ,X (formerly known as Twitter),Facebook andInstagram .

To Mainland China Candidates

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At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.