Regulatory Manager / Responsible Person

Industry: Pharma
Skills: Regulatory Affairs Manager,Qualified Person

Start of project: 01.03.2024 

Duration of the project : 12 Months, with possibility to extend. 

Location: Schaffhausen, Schweiz

This company is specialized in the distribution of medicinal products, medical devices, cosmetics and food supplements.

Our focus is on long-term relationships with Swiss ophthalmologists and pharmacists, providing top quality innovative products, with a high level of advisory expertise and customer service.

Your Role as Responsible Person (FvP): As the Responsible Person (FvP), you will be the guardian of our Quality Assurance System, ensuring adherence to Swiss GMP/GDP requirements. Your responsibilities include product market releases, recalls, handling product complaints, managing deviations, overseeing change controls and assessing Product Quality Reviews. Additionally, you'll play a crucial role during inspections, reviews, and audits.

Your Regulatory Affairs Manager Role: In the capacity of Regulatory Affairs Manager, you will be the bridge between the company and Swiss authorities. This involves handling regulatory submissions for new products and variations, supporting our sales and marketing teams with medico-marketing materials, and ensuring compliance with local regulations. In accordance with art. 25 VAM you will be the responsible person for marketing material approval.

The position is to be filled as soon as possible or by arrangement.

Your Profile:

•You hold the necessary scientific qualifications and experience to be an official RP (FvP).

•At least two years experience as a QP/RP or deputy with in-depth knowledge of GMP/GDP.

•Proven experience with regulatory submissions in the Swiss context.

•A team player with outstanding communication skills and the ability to interact with all levels.

•In-depth knowledge of Swiss regulatory requirements for pharmaceutical legislation.

•Fluent in German and English, with proficiency in French as an advantage.

•Ideally located within 2 hours of Schaffhausen.

What We Offer: This is a senior position, offering a unique opportunity for a QA and regulatory expert to contribute to a small, highly motivated team in Schaffhausen. Our centrally located offices provide flexibility with working hours and the option for regular home office. We foster a dynamic international environment, providing modern training opportunities, a competitive salary, and attractive benefits..