Job Position: Regulatory Affairs Manager
Our company is seeking a dedicated and knowledgeable Regulatory Affairs Manager to contribute to the development of our generic's portfolio.
Position Overview:
You will play a crucial role in ensuring that our medicines reach patients safely and efficiently. You'll lead regulatory strategies, manage submissions across Europe and beyond, and collaborate with cross-functional teams and regulatory authorities to drive successful submissions and lifecycle management.
Key Responsibilities:
1. Lead and coordinate regulatory activities for our medicines portfolio
2. Plan and manage European procedures (MRP/DCP)
3. Provide regulatory support for international pharmaceutical marketing authorisations
4. Develop and execute strategic planning and lifecycle management in and outside Europe
5. Buuild strong relationships with regulatory authorities and internal stakeholders
6. Support local market units in regulatory tasks and submissions
7. Monitor and interpret regulatory requirements and communicate updates to internal teams
8. Collaborate with cross-functional teams to ensure regulatory strategies are aligned with business goals
Required Skills and Qualifications:
* Experience in regulatory affairs (pharma industry)
* University degree in sciences
* Solid knowledge of European regulatory procedures (MRP/DCP) and international frameworks
* Experience in managing variations, renewals, and regulatory lifecycle activities
* Strong communication skills and the ability to work with global teams and external stakeholders
* Proficiency in English; interest in regulatory IT topics
* Detail-oriented, proactive, and eager to take on responsibility
What We Offer:
* A dynamic, collaborative, and supportive work environment
* Opportunities to grow within a leading global pharmaceutical company
* Competitive salary and benefits package
* Exposure to exciting and impactful projects that improve patient access to medicines