Regulatory Affairs Associate Europe
vor 1 Tag
General Description:_
BeiGene is seeking a highly motivated and fast-learning person to support the expansion of clinical trials in Europe in view of clinical trial regulations. This individual will be responsible for timely planning and coordination of regulatory submissions. The Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting and will manage regulatory submissions and regulatory archive.
Essential Functions of the job:
- With some supervision, plan and manage regulatory activities related to assigned projects and markets that span technical areas including clinical, non-clinical, and CMC.
- Work cross functionally with the project team and asist in the preparation, and review of regulatory documents, such as, IB and protocol
- Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory CTA dossiers
- Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support the preparation of meeting requests and briefing documents for health authority meetings.
- Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.
Qualifications:
- Some experience and knowledge in preparation of CTAs, and supportive amendments and supplements (manufacturing, nonclinical, clinical).
- Familiar with the new EU Clinical Trial Regulation and CTIS use
- Understanding of EU/US regulatory basics. 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.
Supervisory Responsibilities:
- N/A
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.
Location: Europe, preferably in Switzerland
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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