Specialist Global Regulatory Affairs Safety, Efficacy & Licensing (m/f/d)

Job Description

We are looking for a Specialist Global Regulatory Affairs Safety, Efficacy & Licensing (m/f/d) to join our team in Schwabenheim, Germany. This position will be a project‑related full‑time contract limited until 31 December 2026.

As a Specialist you will be responsible for Licensing and Data Management in accordance with regulatory submission strategies and timelines and following applicable regulations and guidance.

Major Activities and Responsibilities

• Manage and coordinate regulatory submissions in close cooperation with internal stakeholders and close interaction with the competent authorities.
• Implement and maintain data in the Veeva Vault Regulatory Information Management System (RIM) for regulatory procedures and submissions as Regulatory Information Specialist.
• Submit variations to competent authorities via external regulatory systems, e.g., UPD.
• Ensure compliance with internal and external regulatory standards.

Your Profile

• Bachelor degree or proven related working experience in Life Sciences (e.g., pharmacy, biology, chemistry, biochemistry, supply chain).
• Preferably direct experience in regulatory affairs or other critical areas within the human or animal health industry.
• Working experience with regulatory information systems and platforms (e.g., Veeva Vault).
• Working experience with registration procedures.
• Proven ability to coordinate multiple priorities and meet critical deadlines.
• Good communication, presentation and interpersonal skills, ability to interpret and explain complex information.
• Excellent written and verbal communication skills.
• Proficient in the English language.
• Good team‑player skills.

Benefits

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme.
• Competitive salary package: 13 monthly salaries + holiday pay + target bonus.
• 30 days holiday entitlement.
• Hybrid working model (up to 50% remote).
• Internal training and promotion opportunities.
• International co‑operations.
• Training on the job.
• Contributing your own ideas to the process design.
• Insights into the development of veterinary medicinal products.
• Corporate benefits and free (electric) car parking.
• Good company canteen and a company health management program.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal‑opportunity employer, committed to fostering an inclusive and diverse workplace.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

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