BeiGene Manager, Regulatory Affairs in Helena, Montana
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 person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions.
Essential Functions of the job:
With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC
Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters
Develop and maintain current regulatory knowledge and advise management of significant developments. Ensure compliance with departmental requirements including and maintenance of regulatory archive. Work with external regulatory consultants/CRO’s as required
Education Required: BA/BS degree is required or equivalent experience in a pharmaceutical or health science field
5+ years’ related experience is required
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
Experience with CTD/eCTD
Experience with publishing documents in Adobe Acrobat Professional
Working knowledge of FDA and ICH regulatory guidance and regulations.
Understanding of FDA structure and function
Knowledge/experience with regulatory requirements for other regions also desirable
Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
Excellent oral and written communications skills are a must as are superior planning skills
The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
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.