Regulatory Affairs Specialist

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 and artwork 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 other life science or 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.