Associate Director, CMC Regulatory
Posted on: September 23, 2022
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.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, and Regulatory colleagues, as well as third party
laboratories, global collaborations partners and contract
- 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.
- 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 guidances to the life cycle of a drug product.
- Manage/prepare CMC document packages for regulatory submissions
in support of development programs. This includes initial
submission of INDs, CTAs, and amendments to Health Authorities
(HAs), and preparation of responses to questions from HAs balancing
HA requirements and corporate objectives.
- Manage timelines in cooperation with Project Management on
- 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
- Support and manages regulatory aspects of CMC Operations
including authoring, reviewing and and/or approving SOPs, CAPAs,
- 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
- 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, 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
- Interacts with BeiGene employees and senior management.
- Interacts with external business partners and Regulatory
Agencies.Qualifications:Minimum 7-8 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 SystemTravel for Work: Must be willing to
travel approximately 10-25%Competencies:Ethics - Treats people with
respect; Inspires the trust of others; Works with integrity and
ethically in accordance with BeiGenes Code of Business Conduct and
Ethics, policies and procedures.Planning/Organizing - Prioritizes
and plans work activities; Uses time efficiently; Completes
administrative tasks correctly and on time; Follows instructions
and responds to management direction.Communication - Listens and
gets clarification; Responds well to questions; Speaks clearly and
persuasively in positive or negative situations; Writes clearly and
informatively; Able to read and interpret written
information.Teamwork - Balances team and individual
responsibilities; Gives and welcomes feedback; Contributes to
building a positive team spirit; Puts success of team above own
interests; Supports everyone's efforts to succeed; Contributes to
building a positive team spirit; Shares expertise with
others.Adaptability Able to adapt to changes in the work
environment; Manages competing demands; Changes approach or method
to best fit the situation; Able to deal with frequent change,
delays, or unexpected events.Technical Skills - Assesses own
strengths and development areas; Pursues training and opportunities
for growth; Strives to continuously build knowledge and skills;
Shares expertise with others.Dependability - Follows instructions
and responds to management direction; Takes responsibility for own
actions; Keeps commitments; Commits to long hours of work when
necessary to reach goals; Completes tasks on time or notifies
appropriate person with an alternate plan.Quality - Demonstrates
accuracy and thoroughness; Looks for ways to improve and promote
quality; Applies feedback to improve performance; Monitors own work
to ensure quality.Analytical - Synthesizes complex or diverse
information; Collects and researches data; Uses intuition and
experience to complement data.Problem Solving - Identifies and
resolves problems in a timely manner; Gathers and analyzes
information skillfully.Project Management - Communicates changes
and progress; Completes projects on time and within budget.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.
Keywords: BeiGene, Tallahassee , Associate Director, CMC Regulatory, Executive , Tallahassee, Florida
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