Sintetica

Regulatory Affairs Specialist - Mendrisio Site (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 Specialist.

 

Position summary

The Regulatory Affairs Specialist will provide regulatory support to ensure regulatory compliance and obtain national and international authorizations and their lifecycle maintenance under the direct control of a supervisor.

 

Essential tasks and responsibilities
• Support the preparation, submission, and maintenance of world-wide product registrations in the main global markets:
- NATIONAL (Switzerland, Germany, Austria, UK, and Ireland)
- INTERNATIONAL MARKETS, such as:

  •  NORTH AMERICA (Canada, US, Mexico)
  • LATAM (Central and South America)
  • MENA REGION (Middle East and Africa)
  • ASIA PACIFIC
  • EUROPE (Western and Eastern Europe)

• Critically and autonomously prepare/revise the regulatory documentation for registration purposes (MAA, variations, renewals,etc.) intercommunicating with internal departments, local partners/MAHs, and external consultants
• Constantly remain updated on new regulations issued by HAs and other regulatory organizations
• Review product labeling for compliance with global labeling regulations
• Ensure the registration documents are prepared and kept updated according to the regulatory requests of each relevant Health Authority
• Collaborate with the Quality Assurance and Pharmaceutical Development department to assess the regulatory impact of Change Controls according to the internal SOP
• Ensure that the national texts of Company products are regularly updated and uploaded to national databases, where necessary, either directly or through local partners or consultants


Knowledge and Skills
• 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology)
• At least 4-5 years’ regulatory affairs experience
• Deep knowledge of pharmaceutical legislation and regulations
• Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals).
• Preferably previous experience with global registrations
• Preferably CMC (quality part of the dossier) knowledge
• Organizational skills and regulatory project management skills
• Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, ability to cope with tight schedules, pragmatism
• Ability to resolve conflicts and develop a course of action leading to beneficial outcomes
• Cultural awareness and sensitivity to achieve results across regional, national, and international borders
• Very good English communication and writing skills (knowledge of French or German would be an asset)
• Analytical thinker with strong problem-solving skills
• Commitment to continuous improvement

 

We offer

Fulltime permanent employment in a young working environment and positive culture.

Sintetica promotes diversity and gender equality.

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