Regulatory Affairs Specialist- Animal Health
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Bring energy knowledge innovation to carry out the following:
(may not be limited to):
- Ensure timely preparation submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Ensure maintenance of assigned authorized products through timely submission of variations renewal applications and supplemental marketing authorizations.
- For assigned products ensures high quality labelling translation andartwork management.
- Supports the agency interactions to ensure a seamless submission assessment and quick approval of the CTAs according to the new regulations in cooperation with other internal stakeholders.
- Stay updated on relevant EU and local regulations and guidelines.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts on sub-regional regional and global level our Manufacturing Division EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities as well as other key players in the regulatory environment.
What skills you will need:
In order to excel in this role you will more than likely have:
- Must hold a degree in pharmacy or otherlife scienceor equivalent. An approx. minimum of 1-2 years experience in the pharmaceutical Industry is preferable in a regulatory medical or laboratory position.
- Ability to communicate well verbally and in writing good organizational and planning skills a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work
- A sound appreciation of the interactions and relationships with other groups internally a client-oriented approach and work according to the company leadership vision
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Art Handling Biological Sciences Biomedical Sciences Biostatistics Business Clinical Pharmacy Detail-Oriented Immunochemistry Innovation Life Science Management Process Pharmaceutical Management Product Approvals Regulatory Affairs Compliance ReproductionsPreferred Skills:
Job Posting End Date:
07/24/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
