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
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
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.