MSD Regulatory Affairs Specialist Fixed-term 

Bosnia and Herzegovina, Federation of Bosnia and Herzegovina, Sarajevo 

410220059

Job Description

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 Contingent Workers apply

Project Temps (Fixed Term)

Not Indicated

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