Director Regulatory Affairs

Vor 5 Tagen

Basel, Schweiz BeiGene Vollzeit

General Description:
The Director Regulatory Affairs will be responsible for developing and implementing regulatory strategies for the designated program to secure and maintain marketing authorization in line with business objectives, and in coordination with key internal stakeholders.

Essential Functions of the job:

- Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects
- Lead the regulatory documents, such as, PIP, ODA, and briefing documents for interactions with European regulatory authorities
- Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions and timely approvals
- Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
- Lead and mentor team members
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities.
- Represent the Beigene European regulatory function at industry consortium (maybe required)
- Liaise with other line functions, e.g. legal, compliance, QA, CMC, Operations and Ad/Prormo/Labeling groups to ensure compliance and business continuity

Reports To: Senior Director - Team Lead Regulatory Affairs, Europe and New Markets

Education Required:
Degree in a scientific discipline, or equivalent

Other Qualifications:

- Minimum of 15 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 10 years’ experience in a Regulatory capacity with a broad background.
- Experience working with EMA for EU regulatory procedures is mandatory for this role.
- Sound understanding of the drug development process, the pharmaceutical industry and healthcare environment including Global and EU regulatory requirements and policy trends
- Recent experience with oncology products and MAAs, ODD, PIP is preferred
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- English native speaker is preferred and remote working possible

Location: Europe (remote possible), Switzerland is preferred

Supervisory Responsibilities:
Yes

Computer Skills: Efficient in Microsoft office 356 suite software, e.g., Word, Excel, Outlook, and Adobe

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity

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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