RA Specialist

Summary

Regulatory affairs specialist contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

About the Role

Major accountabilities:

• Ensures timely and high-quality regulatory input for filings and approvals of new marketing authorizations, line extensions, and life cycle submissions.
• Facilitates communication and cooperation between Regulatory Affairs, Quality Assurance, and Supply Chain departments.
• Manages artwork and submission processes in accordance with regulatory standards and local/global SOPs
• Maintains country-specific dossier components and official local drug information.
• Ensures proper archiving of submitted documents and correspondence with Health Authorities.
• Monitors and influences assessment processes to expedite submissions/approvals and negotiate optimal product labeling.
• Proactively tracks and fulfills post-approval commitments to Health Authorities and contributes to risk management planning.
• Collaborates with local brand teams to ensure readiness for product launches.
• Serves as a liaison between headquarters and Health Authorities, fostering proactive engagement with internal and external stakeholders.

Key performance indicators:

• Submissions performed with high quality and on time.
• Timely approval (acc. to agreed timelines) of registrations of new medicinal products and lifecycle management activities, including variations and Safety Label Changes.
• Relevant databases, platforms and product list kept up-to-date
• Compliance with the local regulations and internal procedures.

Minimum Requirements:
Work Experience:

• University degree in pharmacy, medicine or biosciences.
• Min three years experience in Regulatory Affairs.
• Understanding of relevant regulation and approval processes.
• Understanding of regulatory environment in the country.

Skills:

• Analytical Skill.
• Collaboration.
• Detail Oriented.
• Project Planning.
• Regulatory Compliance.
• Organizational, communication, negotiation and interpersonal skills .

Languages :

• English
• Croatian

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Division
Development

Business Unit
Innovative Medicines

Location
Croatia

Site
Croatia

Company / Legal Entity
HR03 (FCRS = HR003) Novartis Hrvatska d.o.o.

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No