Regulatory Affairs Specialist- Animal Health

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

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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: