Senior Manager, Regulatory Affairs, CMC

Beigene Tumwater, WA, WA
senior manager regulatory cmc regulatory cmc management team cross functional marketing lead technical written
November 29, 2022
Beigene
Tumwater, WA, WA
FULL_TIME
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.
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 sectionsfor 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
Qualifications:
- BA/BS degree in scientific discipline, MS/PhD preferred
- 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
- 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
Supervisory Responsibilities:
- The position may have an opportunity to manage a direct report
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
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, 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 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.

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