Experience: 5+ years in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars
Want to know more? ?
At Exeltis, we continue to grow and we are looking for a Regulatory Affairs Biosimilar Specialist ready to take the next step in their career in an international, innovative and high-impact environment.
If you are passionate about Regulatory Affairs, have strong experience in biosimilars, and enjoy defining strategies, anticipating risks and working cross-functionally with different teams, this could be your next great opportunity ?
You will join a strategic role with high visibility across the organization, contributing to the development and registration of complex products in international markets.
What are we looking for? ?
We are looking for an experienced Regulatory Affairs professional with a strategic mindset, strong influencing skills and solid expertise in biosimilars and innovative biopharmaceuticals.
We want to add a proactive,
solution-oriented and collaborative person who can provide regulatory insight, business alignment and strong execution in a integral and evolving environment.
The challenge ?
In this role, you will play a key part in defining and executing regulatory strategies for biosimilars and complex drugs. Your main responsibilities will include:
- Monitoring changes in the regulatory landscape and identifying their impact on the company.
- Defining the regulatory strategy for each product in coordination with the Regulatory Affairs Director, Business Development and Commercial teams.
- Building regulatory plans aligned with business and functional priorities.
- Identifying regulatory risks, defining mitigation actions and driving implementation with cross-functional teams.
- Adapting regulatory strategies in line with evolving regulations and Health Authority feedback.
- Providing regulatory leadership and expert guidance to