24.11.2021
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 (largader@lwphr.ch), who is in charge for the selection. Profiles that do not match what we are looking for will not receive a reply.
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