REQ-10026831
Oct 18, 2024
Croatia

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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Development
Innovative Medicines
Croatia
Croatia
Research & Development
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10026831

RA Specialist

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