Regulatory Affairs Senior Specialist

Qualifications and Experience:

• BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject. 
• Solid and deep knowledge of Regulatory Affairs through working in a Regulatory Affairs related role in the pharmaceutical industry.
• Comprehension of the fast evolving EU and UK regulatory procedures and EU and UK Medicines Legislation.
• Exposure to regulatory submissions and working with a Regulatory Authority would be a strong advantage.
• Excellent verbal and written communication and interactive skills.
• Work on own initiative and take responsibility for managing the day to day regulatory activities for a portfolio of products.
• Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals.
• Able to multitask and manage conflicting priorities with sound time-management skills.
• Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a Regulatory Affairs role in the pharmaceutical industry.
• Ability to identify compliance risks and escalate when necessary

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Required Skills:

Audits Compliance, Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/19/2026

*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.