Requirements: English
Company: Sintetica
Region: Mendrisio , Ticino
Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica''s mission is to continuously strive to improve therapies by enhancing its products'' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
To strengthen our Regulatory Affairs department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Regulatory Affairs Project Manager.
Position Summary
The incumbent is responsible for providing both strategic and operational regulatory support to ensure compliance with relevant regulations, facilitate product registrations in domestic and international markets, and maintain regulatory authorizations throughout the product lifecycle.
Key Responsibilities
- Propose regulatory strategies and manage the preparation, submission, and maintenance of product registrations across global markets, including Switzerland, Europe, North America, LATAM, MENA (Middle East and Africa), and Asia Pacific.
- Provide regulatory support for Medical Devices in accordance with applicable regulations.
- Independently prepare and critically review regulatory documentation (e.g., MAAs, variations, renewals) in collaboration with internal departments, local partners/MAHs, and external consultants.
- Review and ensure product labeling complies with global regulatory requirements.
- Maintain registration dossiers in line with applicable Health Authority requirements, ensuring timely updates and document control.
- Collaborate with Quality Assurance, Pharmaceutical Development and CMC, Non-Clinical & Clinical Development, and Pharmacovigilance to assess the regulatory impact of Change Controls, in accordance with internal SOPs.
Required Qualifications And Skills
- Masters degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Biology, or related field); advanced degree such as Ph.D. constitutes a plus
- Minimum of 10 years of experience in international Regulatory Affairs.
- Strong knowledge of pharmaceutical legislations and regulatory frameworks.
- Proven experience with EU procedures (MRP/DCP, initial MAAs, post-approval changes, extensions, and renewals).
- Solid understanding of Swiss regulatory requirements (initial MAAs, variations, renewals).
- Experience with Medical Device Regulation is a plus.
- Experience with global registrations is highly preferred.
- Knowledge of CMC (chemistry, manufacturing, and controls) is a plus.
- Excellent organizational and project management skills.
- Ability to interpret and clearly communicate regulatory requirements and updates.
- Strong written and verbal communication skills.
- Proactive, autonomous, detail-oriented, strong team player.
- Advanced planning, and time-management skills, ability to work under pressure and meet tight deadlines.
- Proficiency in written and spoken English; knowledge of French or German is a plus.
- Demonstrated commitment to continuous improvement and the ability to anticipate and manage potential regulatory risks.
Preference will be given to candidates of Swiss nationality and residents (Permit B -C)
We offer
- Fulltime permanent employment in a young working environment and positive culture.
- Sintetica promotes diversity and gender equality.
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