Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Global Regulatory Affairs CMC Senior Specialist
Place of work: Belgrade/Vrsac
Type of contract: Fix term - Project based

About the job:

The CMC Global Senior 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.
• Minimum 2 years of relevant experience in preparing regulatory CMC documentation or in a similar regulatory affairs role within the pharmaceutical industry.
• Excellent command of English.
• Proficiency in MS Office and other standard computer applications.

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.