Senior Specialist, Global Regulatory Affairs (m/f/d)

Job Description

The Senior Specialist (m/f/d) Global Regulatory Affairs will support regulatory activities related to new product registrations and life cycle management to ensure efficient new licensing, product portfolio maintenance/ improvement and regulatory compliance and will also align efforts with other ongoing projects. Countries both within and outside the EU are in scope. The position is a full-time position in Schwabenheim, Germany and limited to 2 years.

MAIN RESPONSIBILITIES

• Act as GRA representative and conduct projects e.g., portfolio optimization activities, packaging material updates and implementation of new veterinary regulation.

• Arrange documents, data, and all other items necessary for maintaining marketing authorizations. Ensure timely availability of the requested materials, in line with the licensing strategy.

• Collaboration in the preparation of reports and technical statements with internal and external experts on the respective assigned product classes (e.g., anti-infectives, anti-parasitics, anti-inflammatory drugs, hormones).

• Prepare and coordinate product literature (SPC, leaflet, label) updates according to the current regulations.

• Manage and prepare regulatory submissions, including responses to authority questions as required in each country, to extend or maintain existing product registrations. Ensuring timely submissions.

• Assess post approval changes, provide regulatory filing strategies and timelines.

• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.

• Develop and maintain a strong technical knowledge in pharmaceutical product development, the applicable legal regulations and ensure compliance with internal and external regulatory standards.

• Identify and communicate potential regulatory issues to management, as needed.

• Perform other tasks as requested by management.

BACKGROUND REQUIREMENTS

• University degree in Veterinary Medicine

• Multi-year experience in a safety & efficacy related regulatory position within the animal health industry

• Excellent communication skills

• Proficient in English and MS office applications

• Proficiency with regulatory information management systems (Veeva Vault).

• Advanced level of professionalism: Result-oriented, well-structured way of working, strong interpersonal skills, sound judgement and attentiveness to details

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 medicinal products

• Corporate benefits and free car parking

• Working across borders (20 days per year)

• Paid Parental Time Off (PPTO)

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, Audits Compliance, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Mentorship, New Product Qualification, Pharmaceutical Development, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Pharmacy Regulation, Portfolio Optimization, Process Improvements, Product Approvals, Product Portfolio Management, Product Registrations, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Compliance Consulting, Regulatory Issues {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

02/19/2026

*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: R382252