We have an opportunity for an experienced Regulatory Affairs Manager to join a well-renowned pharmaceutical company for a 12 month contract. You will be supporting the company with a high number of new submissions to Swissmedic. With an extensive portfolio and pipeline, you will be joining at an exciting time of development and will be directly impacting their performance.
- Compile and submit dossiers (NDA and variations) to obtain and maintain Swiss registrations for new and branded products in a range of therapeutic areas
- Be responsible for regulatory compliance of dedicated portfolio
- Manage communication with Swissmedic and interact continuously with internal stakeholders
- Inform and consult other departments within the company on regulatory strategy, variations and regulatory requirements pertaining to gaining authorisation in Switzerland
- Analyse and implement changing Swissmedic requirements
- Adhere to timelines set by the Swiss health authorities
- Coordinate the implementation of the approved variations with internal stakeholders
- 6-8 years’ experience within pharmaceutical regulatory affairs, submissions of MAA and maintaining existing marketing authorisation and lifecycle management, particularly in Swiss submissions
- Deep understanding of Swiss regulations and experience being a key stakeholder in communication with Swissmedic
- Fluent German and English
- Strong work ethic and able to work independently
- Ability to keep all stakeholders informed with strong communication and influencing skills
- Relevant working / residency permit or Swiss /EU-Citizenship
Interested? Please get in touch with an updated CV to firstname.lastname@example.org , and I will be happy to discuss this opportunity and others in Regulatory Affairs in Switzerland.