Specialist Global Regulatory Affairs Safety, Efficacy

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 meeting 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.

Required Skills:

Accountability, Accountability, Adaptability, Biopharmaceutics, Business Strategies, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, English Language, Immunochemistry, In Licensing, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Management, Regulatory Project Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Samarind RMS {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

12/20/2025

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R374228