Director, Regulatory Affairs, Cmc

vor 2 Wochen

Baar, Schweiz Biogen Vollzeit

**Job Description**:
**About This Role**

The Global Regulatory Reg CMC Lead is responsible for the line management of the team members reporting into him/her, with responsibilities for commercial activities for the designated small molecule products. The CMC GRL provides regulatory CMC leadership on cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices.

**What You’ll Do**
- Develop soft and technical skills, ensuring coaching and mentoring of the assigned team, and conduct performance assessment.
- Ensure the development of the Global RegCMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority interaction and influence).
- Accountable for review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
- Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
- Ensure effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
- Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with Health Authorities in all regions.
- Partner with regulatory regional leads for exchange of project/product related information and submission planning.
- Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
- Monitor and influence changes in the global Regulatory CMC environment in alignment with business needs.
- Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.

**Qualifications**:
**Who You Are**

You are passionate about leading dynamic programs and are excited about taking part in developing transformative treatment for patients. To do so, you have proven leadership and abilities to work cross-functionally and across cultures, you hold strong communication, regulatory CMC knowledge for complex small molecules and interpersonal skills.

**Required Skills**:

- At least 10 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8+ years of experience in Regulatory CMC, including 2-3 years in Commercial Regulatory CMC working with small molecules.
- Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
- Demonstrated inclusive leadership, emotional intelligence and strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
- Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
- Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
- BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
- Recognized experience in people development and management (experience with managing 1-2 direct reports is a must).

Additional Information

The Global Regulatory CMC Lead assigns activities to the team members, supports the team members in setting regulatory CMC strategies and their daily work. He/she ensures coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities.

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