Junior Regulatory Affairs Specialist

Job Description

Basic Functions & Responsibility (may not be limited to):

After completion of all necessary training:

• Supports RA team members to ensure compliance in uploading relevant data in RA data bases, internal systems and platforms.

• For assigned products and under supervision ensures maintenance of assigned, authorized products through timely submission of variations.

• For assigned products and under supervision ensures high quality labelling translation and artwork management in appropriate systems.

• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.

• Ensures that files and archives related to Regulatory are kept updated and complete.

• Keeps abreast of local and international laws in regulatory environment.

Qualifications, Skills & Experience:

- B.Sc. in pharmacy or other life science or equivalent will be an advantage (not required).

- Experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.

- Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.

- The candidate should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.

- Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment.

- The candidate must demonstrate proficiency in Polish and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.

- Experience in a Regulatory Department, dealing with most aspects of registration, will be an additional advantage.

Required Skills:

Adaptability, Biopharmaceutical Industry, Client Registration, Communication, Database Applications, Databasing, Detail-Oriented, International Human Rights Law, International Regulatory Compliance, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

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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:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/16/2026

*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.