Regulatory Affairs Specialist

Our client is an international solid, responsible and growing pharmaceutical company based in Ticino. For this exclusive research, we are looking for a successful candidate to fill the position of: REGULATORY AFFAIRS SPECIALIST

full time permanent employment in a young working environment and positive culture.


Position summary:

The Regulatory Affairs Specialist will provide regulatory support to ensure regulatory compliance, to 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 product registrations with a focus on European, Swiss and US regulations. Knowledge of other international markets would be advantageous.
  • CMC knowledge is recommended
  • Collaborate with internal departments to obtain and understand registration requirements.
  • Identify and interpret regulations issued by applicable regulatory agencies and other regulatory organizations.
  • Review product labeling for compliance with global labeling regulations.
  • Improve regulatory intelligence by attending regulatory seminars and meetings.


Knowledge and Skills:

  •  Working with policies, procedures and SOPs.
  • Knowledge of legislation and regulations relating to marketing authorizations, post-approval changes, extensions and renewals.


Position skills and requirements:

  • Degree in a scientific discipline (Pharmaceutical Science, Chemistry and / or Biology.
  • 5 – 6 years regulatory affairs experience.
  • Good English communication and writing skills in the context of reports and business correspondence (knowledge of French would be an asset).
  • Knowledge of Swiss/ EU regulations and procedures such as MRP, DCP Centralized procedure and pharmaceutical life cycle.
  • Able to work independently and complete assigned tasks within established deadlines.
  • Analytical thinker with strong problem-solving skills.
  • Strong attention to detail.
  • Commitment to continuous improvement.
  • Proficiency in MS Office: Word, Excel, PowerPoint.


Scientific / Technical Excellence:

  • Team work.
  • Communication skills – both oral and written.
  • Organizational skills & regulatory project management skills.
  • Ability to understand and communicate scientific/clinical information.
  • Ability to anticipate and prevent potential issues.
  • 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.
  • Demonstrated experience working effectively in regulatory and cross-functional teams.


Interested candidates should send their CV by email to Cristina Robotti at or by post to the address below.

For further information please call the following number: +41 91 911 30 00.

We thank all applicants for their interest, but only candidates selected for an interview will be contacted.



Luisoni Consulenze SA
Cristina Robotti
Vice Direttrice
Via Balestra 9
6900 Lugano


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