Team Lead Regulatory Affairs CH / EU (f/m) 100%
Acino is a Swiss pharmaceutical company, leader in advanced drug deliverytechnologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.
Your main responsibilities may include:
- Leading and developing team members
- Leading the CMC team and providing CMC support
- Establishing and maintaining a functional RA-entity in CH/EU-region by integrating internal and external parts of regulatory groups (HQ, CMC-team, Labelling team, ext. consultants)
- Fulfilling all regulatory activities (new submissions, maintenance, renewals etc.) for marketed products as agreed with Commercial Operations within CH/EU-region
- Maintaining collaboration with Commercial Operations to contribute to implementation of business goals
- Improving regulatory affairs team effectiveness within CH/EU regional team and strengthening the collaboration with the RoW-RA-team
- Integrating and supervising RA functional activities within CH/EU region
- Monitoring regulatory policies evolution and ensuring compliance focusing on CH/EU region
- Minimum educational requirements are a Master’s Degree in Pharmacy, Chemistry, Biology or another life science
- More than 8 years of experience in Regulatory Affairs in pharmaceutical industry, preferably with within generics business and including solid leadership experience
- High proficiency in European legislation and ideally also CH (experience with creation, review and finalization of MA applications as well as variation packages)
- Good network and experience with Health Authorities in Switzerland and Europe
- Preferably: Computer literacy (MS-Office-Tools), good understanding of database and document management systems (docuBridge)
- Languages: Fluent in writing and negotiation both in English and German
- Ability to work cross-functionally and in an international environment
- Proactive, driving attitude
- Target oriented personality, able to work under pressure and on multiple tasks simultaneously; market focus and business acumen
- Excellent planning and organizational skills and ability to drive the regulatory process with a sense of urgency, both internally through multi-disciplinary teams and externally through the effective use of third parties as well as effective communication and negotiation with regulatory authorities
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! Please send us your complete application to – preferably via e-mail into one PDF document – to Ms. Emmanuelle Leblanc.
Emmanuelle Leblanc/ HRBP&Talent Acquisition / firstname.lastname@example.org
We are looking forward to the opportunity to get to know you.
Only direct applications are considered
Apply & Further Information
To apply we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to our HR team through the email listed below. The team is also happy to respond to any questions about the role or Acino, that you might have.
We are looking forward to hearing from you. Only direct applications are considered.Job list