Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA. 

Regulatory Global CMC Specialist – Regulatory Operations
Place of work: Belgrade
Type of contract: Fixed term

About the job: 

As a Regulatory Global CMC Specialist in Regulatory Operations, you will play a key role in achieving IDMP (Identification of Medicinal Products) readiness by ensuring the accuracy and compliance of substance data in our internal formula code database (FCDB). You will work closely with Global Regulatory Affairs, Regulatory Operations, and Regulatory CMC teams. In this role, you will independently plan and implement project tasks, making autonomous decisions to drive progress while fostering collaboration across department.

Responsibilities:

• EMA SPOR Compliance, maintain a strong familiarity with EMA SPOR (Substance) regulations and guidelines, applying this knowledge to our processes and data.
• Data Updates & Maintenance, perform critical updates to substance-related entries in the internal FCDB, ensuring all data meets the latest EMA requirements (e.g., updating substance flags or other key data points for compliance).
• Stakeholder Communication, understand the impact of new EMA regulations and clearly communicate these requirements to relevant stakeholders. Acting as a liaison, you will ensure that cross-functional teams are aligned and aware of regulatory changes.
• Issue Resolution with EMA, manage substance-related discrepancies by creating and handling tickets with EMA. This includes following up on issues and collaborating with EMA representatives to resolve any data discrepancies promptly and effectively.
• Database Management, work extensively with regulatory databases, updating records, creating new entries, and performing regular maintenance to keep data accurate. You’ll ensure all database activities adhere to EMA compliance deadlines and reporting requirements.
• IDMP & PMS Submission Support, support preparations for IDMP and PMS (Product Management Service) submissions by mapping and entering data, cleaning up existing records, and maintaining high data quality standards. Your work will directly support successful and timely submissions.
• Testing and Validation, contribute to testing and validation processes as part of our IDMP readiness efforts. Using understanding of validation methodologies, you will help verify that updates and new systems function correctly and meet regulatory standards.

Qualifications: 

• University degree in pharmaceutical, chemical, or technological sciences (e.g., Pharmacy, Chemistry, or a related field). Alternatively, you have at least 5 years of relevant work experience in the pharmaceutical industry or in a pharmacy setting (for example, as a pharmacy technician) that compensates for a formal degree.
• Minimum of 1 year of experience in Regulatory CMC writing or a similar regulatory affairs role, giving you a foundation in regulatory documentation and compliance processes.
• Proficient in English, both written and spoken, enabling you to effectively communicate in an international regulatory environment.
• Possess strong computer skills and are comfortable working with databases and regulatory IT systems.
• Quickly adapt to new software tools and ensure data integrity in all your tasks.
• Working in cross-functional teams and can collaborate closely with colleagues from Regulatory Affairs, Regulatory CMC, Regulatory Operatiosn and other departments. Communicate clearly and build positive working relationships to achieve shared goals.
• Track record of meeting strict deadlines, especially related to regulatory submissions and EMA compliance timelines. Organized approach and attention to detail enable you to deliver quality results on time.
• Sharp analytical and problem-solving skills, especially when it comes to handling data. Whether it’s entering new information, performing data cleanup, or mapping fields for IDMP, you approach these tasks methodically and meticulously.

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.
• Mental health and well-being support for employees and their families through the Kyan Health app.

Only shortlisted candidates will be contacted.