Senior Manager, Regulatory Affairs, CMC

BeiGene 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 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 to meet aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies.

Essential Functions of the job: 

• 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.

Computer Skills: Microsoft 360

Other Qualifications:

• 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, MS/PhD preferred.

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

• Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus. Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections. 

• 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.
   

Travel:  0-5%

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.