To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs (RA) Team, we are looking for a Regulatory Affairs Senior Specialist / Manager (temporary for 2 years, with prospect of permanent position, 100%, f/m/d).
You will take full responsibility for your assigned projects/tasks while benefiting from working within a highly motivated and innovative team.
Your tasks
* Key role within the implementation process of a new Regulatory Information Management System and coaching of RA colleagues.
* Identification of areas for improvement within the RA unit and RA-stakeholder interfaces. Initiation of appropriate initiatives driving innovation, modernization, and enhancement of processes.
* Hands‑on writing and review of regulatory documents of different backgrounds in accordance with applicable regulatory rules and guidelines.
* Support of RA colleagues with projects, gradually develop into representation of RA in customer projects.
* Coordination of responses to RA‑related customer requests.
* Coordination of responses to authority requests in close collaboration with our customers.
* Delivery of regulatory advice to internal and external stakeholders.
* Review of documents and assessment of GMP changes from RA perspective.
* Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.
Your profile
* University degree Master and/or PhD with focus on Natural Sciences (Chemistry, Pharmacy, or similar field).
* At least 2 years of professional experience in an RA function.
* Experience with Regulatory Information Management Systems (preferably Veeva).
* Experience with migration and/or implementation of IT projects is a plus.
* Strong communication and collaboration skills and strategic mindset.
* Flair for presenting scientific facts.
* Committed and well‑structured work‑attitude.
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