Associate Director, Regulatory Affairs, CMC

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.

Position Summary:

The AD, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases of development, post-approval, and life cycle of the product depending on assigned products. Primary responsibilities will be in creating CMC regulatory strategies for development programs in preparation and maintenance of regulatory applications.

Essential Functions of the Job:

• Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.

• Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.

• Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams.

• Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product.

• Manage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. This includes initial submissions, amendments, and preparation of high-quality responses to Health Authority questions, balancing regulatory requirements with corporate objectives..

• Manage timelines in cooperation with Project Management on assigned projects.

• Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with regulatory requirements, strategies, and commitments.

• Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.

• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.

• Actively participate as a member of global regulatory teams and CMC subteams.

• Support and manages regulatory aspects of CMC Operations including authoring, reviewing and and/or approving SOP’s, CAPA’s, etc. •

• Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.

• Other duties as assigned.

Core Competencies, Knowledge and Skill Requirements

• Expertise in development and commercial product lifecycle (Phase 1-3, Marketed products).

• Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required, global submission experience desired.

• A good understanding or IND, CTA, IMPD, BLA and MAA processes.

• Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.

• Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.

• Demonstrated ability to coach, train and mentor teams.

• Strong negotiating skills and ability to think creatively and develop creative solutions.

• Ability to prioritize and handle multiple projects simultaneously.
   

Communication & Interpersonal Skills

• Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.

• Proven ability to build trust and respect within the organization.
   

Significant Contacts

• Interacts with BeiGene employees and senior management.

• Interacts with external business partners and Regulatory Agencies.

Qualifications:

Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products).

Education Required: BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred.

Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), Veeva Data Management System

Travel for Work: Must be willing to travel approximately 10-25%

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

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 accommodationsus@beonemed.com.