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Regulatory Affairs Specialist   

Standort: Schweiz, Tessin, Lugano

Datum: 09/01/2019

Branche: Pharma-Industrie

Funktion: Anderes

Aktivitäten 

Stellenbeschreibung

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Bewerben

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.