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 infoluisoni@luisoni.ch 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.

 

MAXIMUM DISCRETION AND PROFESSIONALISM FULLY GUARANTEED.

Luisoni Consulenze SA
Cristina Robotti
Vice Direttrice
Via Balestra 9
6900 Lugano
0041919113000
infoluisoni@luisoni.ch

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