Regulatory Affairs Associate Director, Europe
vor 2 Wochen
REGULATORY AFFAIRS Associate Director, Europe (with focus on Switzerland)
Regulatory Affairs, Basel, Switzerland
Reports To: Director, Team Lead of EU Regulatory Affairs
**Job Description**:
The (Swiss) Regulatory Affairs lead will report to the team lead of Regulatory Affairs Europe and will have dotted line reporting to the Swiss General Manager. The role will be responsible for developing and implementing Swiss regulatory strategies for development programs to secure and maintain marketing authorization for products in line with business objectives, and in coordination with key internal stakeholders. This newly created role will:
- Provide regulatory strategies, especially with regard to Switzerland, for product development; writing and review of internal and external documentations to support development programs
- Manage the content of regulatory dossiers. Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
- Prepare team for Swissmedic interactions, may be required to moderate and lead discussions
- Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory procedures, changes, and trends
- Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions
- Ensure compliance with Swiss regulatory requirements.
- Provide GxP expertise and supervise the pharmaceutical business within the UK and ensure the correct handling of medicinal products
- Ensure that the requirements of all relevant national and international guidelines and internal policies/SOPs are met, considering the requirements of Swiss marketing authorisation as well as EU GxP Guideline
- Act as European RA lead for designed projects and lead CTAs at European level.
Core Competencies, Knowledge and Skill Requirements:
- Minimum 8 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background.
- Experience working with Swissmedic regulatory procedures is mandatory for this role.
- Good understanding of the drug development process, the pharmaceutical industry and healthcare environment including Global and Swiss regulatory requirements and policy trends
- Recent experience with oncology products, global alliance procedures and CTAs are preferred.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
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.
Computer Skills:
Efficient in Microsoft Word, Excel, and Outlook
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 b
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