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 Expert

Place of work: Belgrade

About the job:

As Regulatory Global CMC Expert within the organizational unit Global Regulatory Affairs, Regulatory CMC- New Products, you will be responsible for drafting and coordinating regulatory documentation for new registrations, product maintenance (renewals and variations), and clinical trial study dossiers to ensure compliance with chemical-pharmaceutical quality standards globally, as well as independently managing projects, coordinating responses to agency requirements and monitoring CMC trends.

Responsibilities:

• Responsible for drafting regulatory documents related to the chemical-pharmaceutical quality of the drug (Modules 2.3 and 3) for new registrations and then for product maintenance activities (renewal and variation) and preparation of the Study Dossier (IMPD) (dossiers for clinical trial medicinal products). As well as activities related to the evaluation/assessment of registration dossiers at the global level.
• Defines and organizes the activities to be performed as part of preparing the response to the Agency's requests during the new registration and/or renewal and variation procedure in Module 3, which includes: professional documentation procedure and coordination of necessary organizational units, respecting regulatory deadlines.
• Independent planning and implementation of the project task and making own project-related decisions.
• Manages projects, reports and takes responsibility for products.
• Follows trends and news from relevant special CMC areas and organizes and participates in the implementation of education of employees in the organizational unit.
• Functionally represent the team lead in case of absence of the team lead.
• Involved in due diligence projects.
• Acts as advisor for other departments as necessary and is taking care for supervisory activities within the team and department.

Qualifications:

• University degree of pharmaceutical, chemical or technological education (Faculty of Pharmacy, Chemistry or Technology), or compensable with minimum of 5 years' work experience in pharmaceutical industry or pharmacy (f.e. pharmacy technician).
• Minimum 4 to 6 years' experience in CMC writing or similar job.
• Good knowledge of English and Microsoft Office skills.
• In-depth and excellent knowledge of CMC requirements and ongoing activities.
• Leading of several special (non-routine) projects or establishing of special knowledge which supports activities of the department (f.a. analytical expertise, pharmaceutical technology, special kind of products (specialty products)).
• Independent work.
• Convincing presentation skills for decision making.
• Taking a final decision in cases where that is necessary.
• Ability to correct assessments of CMC related questions.
• Ability to advice other departments and to take over function as supervisor in global CMC department

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

Only shortlisted candidates will be contacted.