Job Description Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. For our innovative research location in Schwabenheim (near Mainz), we are looking for a full-time and initially limited to 2 years Senior Specialist Regulatory Affairs (m/w/d) – CMC – Site Transfers (#ILC/ Project pink) as soon as possible. The focus of this position is on the processing of variations for multiple products within the scope of a defined project in close coordination with colleagues within the global regulatory affairs team and the responsible finished product manufacturing facilities. Main responsibilities: Global Regulatory representative within the project Evaluation of requirements for registered markets and necessary variations and/or marketing authorization transfers Preparation and submission of identified variations and/or marketing authorization transfers Maintenance and updating of regulatory CMC dossiers (Co-)development of regulatory concepts and preparation of documentation for change notifications, taking into account current regulatory quality standards Timely response to inquiries from countries and authorities Technical support of other functions in regulatory issues Collection and maintenance of regulatory information, taking into account the associated processes, as well as maintenance of the relevant systems and databases Act as Regulatory Information Specialist in Veeva Vault Your profile: Master's degree in Pharmacist, Chemist, Food Chemist or Biologist Ideally, you have professional experience in comparable positions in the pharmaceutical industry. However, applications from university graduates are also welcome. Consistent, flexible, team-oriented and familiar with MS Office Careful and responsible way of working You combine organizational skills with strong communication skills in an international environment Very good verbal and written language (English essential, German & Italian desirable) Our offer: 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 (depending on location) Hybrid or remote working model (depending on location) 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. 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: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Adaptability, Adaptability, Communication, Detail-Oriented, Employee Training Programs, Executive Communications, Immunochemistry, Maintenance Management, Management Process, Microbiology, Organizational Communications, Pharmaceutical Management, Pharmaceutical Regulatory Affairs, Phytochemistry, Product Approvals, Professional Etiquette, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Submissions {+ 4 more} Preferred Skills: Job Posting End Date: 09/11/2025 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
