Regulatory Strategy Lead

vor 4 Wochen


Lausanne, Schweiz ALTOGEN AG Vollzeit

ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

To strengthen our team in **Switzerland**, we are looking for a **Regulatory Strategy Lead (M/F/x).**

**ABOUT THE JOB**:

- Develop, implement, and sometimes lead regional regulatory strategies to ensure efficient product development and timely approvals.
- Assess and communicate the potential for success of regulatory strategies, aligning with program objectives.
- Provide regional strategic and tactical guidance to teams, ensuring full regulatory compliance throughout development programs.
- Lead regional regulatory teams and represent the EUCAN region in global project meetings.
- Manage regulatory submissions for the European region, working with regulatory authorities like the EMA and local agencies to support product approvals.
- Partner with market access teams to align on regional strategy and collaborate with national regulatory and health agencies on evidence and value discussions.
- Stay updated on regulatory requirements, trends, and emerging issues, providing insights and guidance to global teams.

**About you**:

- Bachelor’s or advanced degree in a scientific field; advanced degree preferred.
- Significant experience in pharmaceutical regulatory affairs, particularly within EU regulations, both in development and post-marketing phases.
- Proven expertise in regulatory submissions, working knowledge of EU guidelines, and experience in managing interactions with regulatory authorities.
- Strong communication skills, project management, and the ability to work collaboratively within a global, cross-functional environment.
- Ability to provide creative, strategic solutions to regulatory challenges and adapt to evolving regulatory landscapes.
- Assess and communicate the potential for success of regulatory strategies, aligning with program objectives.
- Provide regional strategic and tactical guidance to teams, ensuring full regulatory compliance throughout development programs.
- Lead regional regulatory teams and represent the EUCAN region in global project meetings.
- Manage regulatory submissions for the European region, working with regulatory authorities like the EMA and local agencies to support product approvals.
- Partner with market access teams to align on regional strategy and collaborate with national regulatory and health agencies on evidence and value discussions.
- Stay updated on regulatory requirements, trends, and emerging issues, providing insights and guidance to global teams.

**_**_
- *_*

**WHAT WE OFFER**:

- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and an integration within the "Tribe"

**Job Types**: Full-time, Permanent

Schedule:

- Monday to Friday

Work Location: In person

**Job Type**: 100%

Schedule:

- Day shift

Work Location: In person



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