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Regulatory Affairs Specialist
Il y a 3 mois
Are you eager to become part of a pioneering and dynamic organization within the Life Sciences industry?
At Elitys, we provide a unique experience in engineering career consulting and management. Our core values center around infusing meaning into work and recognizing its worth.
We firmly believe that progress is achieved through the enhancement of professional capabilities and the promotion of individual initiatives.
Our goal is to serve as a reliable source of advice and support for each of our engineers throughout various phases of their careers.
Is Elitys the ideal environment for you?
- You aspire to be part of a company that mirrors your values and fosters personal development
- You thrive on learning and growing through collaborative efforts
- You find motivation in sharing your expertise and insights with peers
- You seek to take charge of your professional journey
- You desire a workplace that champions your personal interests
Your key responsibilities:
Registration:
- Compile marketing authorization application documents (initial requests, modifications, and post-authorization tasks)
- Oversee Marketing Authorizations for pharmaceutical products (registration and modifications)
- Assist in drafting Module 1 documentation
- Ensure adherence to regulations for additional healthcare products
- Proactively identify and relay regulatory updates to pertinent departments
- Engage in the formulation of regulatory strategies
Project Management & Oversight:
- Lead or engage in essential working groups for brand maintenance and new product introductions
- Facilitate or participate in necessary working groups for ongoing and new launches
Cross-functional Collaboration:
- Work collaboratively across various departments (Business, Quality, Pharmacovigilance, Supply Chain)
Profile requirements:
- Pharmacist with a doctoral degree/eligible for registration
- At least 2 to 3 years of experience in a laboratory or operational environment
- Experience with submissions in the France or Europe region
