Job Description
We are looking for a Senior Specialist Regulatory Affairs CMC (m/w/d) to join our team in the innovative research location in Schwabenheim (near Mainz). Scope of the position is supporting the studies and documentation for the CMC part of the dossier needed to gain new registrations of Animal Health pharmaceutical products throughout the world.
This position is a full-time and temporary contract for 12 months.
MAIN RESPONSIBILITIES:
- Collaborate cross-functionally with manufacturing, quality, technical support, R&D, in close coordination with the main project responsible CMC AD
- Work with the project team, CORAs and the CMC AD to ensure all important CMC
- Support the development and maintenance of standard processes and systems to maintain regulatory information to support regulatory compliance. This may involve participating in complex projects related to these processes or systems
- Maintain and foster current in depth knowledge and experience applying the EMA, FDA, VICH, and other country specific CMC/Quality related guidelines to pre- and post-approval CMC submissions
- Providing documentation to countries including creating and maintaining the corresponding documents and binders in Alexx submissions
- Supporting "senior" team member (CMC AD) during LOQ-A phase by e.g., tracking
- Supporting the CMC project team member in various project activities such as Gap & Risk assessment, kick-off meetings (CORAs)
- Checking submitted or registered status with CORAs and compiling variations needed for countries before launch in case relevant changes happened during registration in US or EU to ensure compliance
- Participate on new product development teams as well as other types of teams
YOUR PROFILE:
- Minimum B.S. in pharmacy, chemistry, or science degree
- Experience in preparing CMC sections in the Common Technical Document format
- Experience in preparing US supplements, and EU variations
- Experience critically reviewing detailed scientific information
- Good understanding of related fields (manufacturing, analytical, quality assurance, and R&D)
- Strong written and verbal communication skills in multicultural settings
- High level of professionalism
- Proficient in English
People with severe disabilities and their equivalents will be given preference if they are equally qualified.
Required Skills: Accountability, Accountability, Adaptability, Chemical Biology, Chemistry, Detail-Oriented, Documentations, Employee Training Programs, Intercultural Communication Training, Manufacturing, Mentorship, New Product Introduction Process, Pharmacy Laws, Pharmacy Practice, Professional Etiquette, Project Coordination, Project Management, Quality Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Submissions {+ 3 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: 01/17/2026
*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: R378812
Job Tags
Full time, Temporary work, Fixed term contract, Relocation, Visa sponsorship, Flexible hours, Shift work,