Job Description

Are you a motivated professional with a keen interest in regulatory affairs within the innovative pharmaceutical industry? We are currently seeking a dedicated Regulatory Affairs Specialist to join our team. In this role, you will play a vital part in ensuring our medicines meet the highest regulatory standards, allowing us to deliver safe and effective medicines to our patients.

Position Type: Fixed-term Contract until end April 2026

Key Responsibilities:

Marketing Authorization Applications: Under the guidance of the Country Lead/Senior Specialist, prepare and submit new Marketing Authorization applications to local authorities, ensuring timely follow-up and compliance with regulatory requirements.Maintenance of Products: Ensure that all authorized products are maintained by submitting timely variations, renewal applications, and supplemental marketing authorizations.Labeling and Artwork Management: Oversee the quality of labeling translations and manage artwork processes for assigned products, ensuring adherence to industry standards.Regulatory Intelligence: Stay updated on relevant EU and local regulations and guidelines while collecting and sharing pertinent regulatory information with relevant teams.Relationship Management: Foster positive relationships with internal teams and external regulatory authorities, ensuring effective communication and collaboration.

Major Activities:

Perform timely submissions and maintain tracking of new Marketing Authorization applications in cooperation with various departments.Ensure compliance by preparing and maintaining regulatory documents such as the Summary of Product Characteristics and Patient Package Inserts.Prepare and manage artwork documentation, conducting thorough reviews to ensure accuracy and compliance.Participate in cross-functional activities to address regulatory challenges while providing strategic advice during product launches.

Qualifications:

Education: Minimum B.Sc. in Pharmacy.Experience: Approximately 2 years of experience in the pharmaceutical industry, particularly in regulatory, medical, or laboratory roles.Skills: Strong verbal and written communication skills in both the local language and English, with excellent organizational and planning abilities. Attention to detail and flexibility are essential to manage high-pressure situations effectively.Technical Proficiency: Proficient in PC applications, including word processing, spreadsheets, and databases.

Why Join Us?

Contribute to Innovation: Be part of a dedicated team that impacts patient health through effective regulatory compliance and product management.Professional Development: Enhance your skills and experience in a supportive and collaborative work environment.Work-Life Balance: Enjoy a role that offers a balance between independent and collaborative work.

Application Process:

If you are ready to make a difference in the pharmaceutical sector and meet the qualifications outlined above, we invite you to apply. Please submit your resume and a cover letter detailing your relevant experience.

Application Deadline: 15th of January 2025

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:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/16/2025

*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.

Requisition ID:R327914