Candidatura

On behalf of our client, an European pharmaceutical company based in Ticino, we are currently searching for the following candidate:

REGULATORY AFFAIRS OFFICER

 

The position is in the Regulatory Team, referring directly to the Regulatory Affairs Coordinator.

The Employee will support regulatory activities for a product as the regulatory representative on assigned product teams. He/She will work with the Regulatory Affairs Coordinator and functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities.

Main Job Tasks, Duties and Responsibilities

  • Assist the RA Coordinator on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members

  • Assist the preparation of regulatory submissions including routine correspondence

  • Assist to Provide critical review of all documentation supporting regulatory applications

  • Assist to Provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management

  • Contribute to Plan, prepare and support meetings and teleconferences with regulatory agencies and submission meetings; may also be required to work with government funding agencies

  • Contribute to Prepare responses to complex questions and comments from regulatory agencies

  • Assist to Ensure regulatory product compliance for product (e.g. agency commitments)

Education and Experience

  • Bachelor’s degree in a life sciences or related discipline required. min 3+ years of relevant pharmaceutical industry experience. in Regulatory Affairs is preferred

  • Experience interacting with the Swissmedic, EMA and/or other agencies as required is preferred

  • Multilingual – English fluently spoken and written is requested.

  • Switzerland are preferred site of residential

Key Competencies

  • A wide degree of flexibility, multitasking and open-minded attitude with ability to prioritize multiple tasks

  • Identifies priorities and key issues in complex situations and solves with minimal assistance

  • Exercises judgement within generally defined regulatory practices and policies

  • Experienced in leading cross-functional interactions related to regulatory matters

  • Understanding of regulatory issues and their touch points

  • Ability to anticipate and prevent potential issues

  • Attention to detail and ability to manage work complexity

  • Communication skills - verbal and written: active listening, effective message delivery, empathy, proactive attitude

  • Planning and organizing

  • Data collection, management and analysis

  • Problem analysis and problem solving and decision-making skills

  • Customer service orientation

  • Effective interaction with stakeholders

  • Teamwork

 

Language: Italian, English

 

If your experience matches the described requirements, you may apply to Mr. Alberto Largader ([email protected]), who is in charge for the selection. Profiles that do not match what we are looking for will not receive a reply.

 

Ledermann
Via Vegezzi 4
6900 Lugano

Ledermann Wieting & Partners SA
+41 (0) 91 921.48.78
+41 (0) 91 921.45.69