Global Regulatory Affairs CMC Specialist

Global Regulatory Affairs CMC Specialist Place of work: Belgrade/Vrsac About the job: The CMC Global Specialist is responsible for preparing, maintaining, and coordinating high-quality regulatory CMC documentation in accordance with global regulatory requirements. This role supports product registrations, lifecycle management, and clinical trial applications while ensuring compliance with applicable regulatory standards.

The position requires close collaboration with cross-functional teams, independent project management, and proactive contribution to continuous improvement initiatives within Global Regulatory Affairs.

Responsibilities

Prepare, maintain, and ensure compliance of regulatory CMC documentation (Modules 2.3 and 3) for new registrations, lifecycle management activities, and Investigational Medicinal Product Dossiers (IMPDs). Coordinate responses to health authority requests during registrations, renewals, and variations, ensuring accurate documentation and timely submissions.

Independently manage regulatory projects, monitor progress, and ensure successful implementation of assigned activities. Collaborate with cross-functional teams to support regulatory processes while ensuring compliance with applicable regulatory requirements and quality standards. Monitor regulatory trends, contribute to continuous process improvements, and organize or participate in knowledge-sharing and employee training initiatives.

Support departmental objectives by participating in strategic projects, including the Variation Backlog Reduction initiative, and performing other tasks assigned by the supervisor.

Qualifications

Bachelor's degree (at least a Bachelor's or equivalent) in pharmaceutical, medical, or technological fields, with a focus on pharmacy, medicine, or technology. This includes degrees from Pharmaceutical, Medical, or Technological faculties. Alternatively, candidates with a lower level of education should have at least 5 years of relevant experience in the pharmaceutical industry or pharmacy.

Excellent command of English. Proficiency in MS Office. We offer: Private healthcare insurance (with the option of privileged usage for family members) Ongoing professional development through specialized education and training A platform for learning 14 foreign languages, using various learning styles, including conversation courses Personalized mental health and well-being support for employees and their families through the Kyan Health app New year bonus Only shortlisted candidates will be contacted.