Job Title:  Senior Regulatory Affairs Manager

Role Details

Senior Regulatory Affairs Manager

Role: Full time, Permanent

Location: Bottmingen, Switzerland

Salary: Competitive + bonus + benefits

The Role

We are seeking a Senior Regulatory Affairs Manager to join the team in our Swiss office. You will have full and autonomous responsibility for obtaining and maintaining the Swiss marketing authorisations (MAs) for our pharmaceutical products. You will carry out periodic checks of originator SmPCs/PILs to ensure that the labelling of our products is up to date. You will review and approve for manufacture of packaging material and leaflets as well as provide support in new product launches.

• Updates of the SmPC/PIL of generics and original products
• Submission of PSURs
• Review and approval for manufacture of packaging material and leaflets.
• Support PV with communication of safety signals
• Stay up to date with regulatory guidelines and requirements in Switzerland
• Communication with HQ and document archiving
• Provide support in new product launches e.g. prepare short SmPCs
• Provide data for marketing materials

Other: Depending on qualifications, may act as the local pharmacovigilance contact person.

The Person

•Pharmaceutical or natural science degree

•Demonstrable experience in a comparable role within a Swiss MA holder

•Good knowledge of the Swiss regulatory framework and the current requirements regarding pharmaceutical products

•Proven experience with autonomous submission to Swissmedic of new MA applications and variations

•Experience with original products would be desirable

•Experience in quality assurance, GMP/GDP

•Fluent in English and German – spoken and written

•Basic knowledge in French and/or Italian would be useful

•Experience or knowledge of pharmacovigilance would be an advantage

•Is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration.

•Relates well to other people within the global organization; builds constructive and effective relationships.

•Good at figuring out the processes necessary to get things done; knows how to organize activities; understands how to separate and combine tasks into efficient workflow.

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 01/06/25. For more information, you can contact us on: careers@accord-healthcare.com

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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