Senior Regulatory Affairs Specialist

Heads Talent Solutions has partnered with AbbVie, a research-based biopharmaceutical company, to support their expansion in Belgrade. 

The role: 

• Ensures that all regulatory submissions are prepared, filed and approved in a timely manner to meet business targets covering all AbbVie products in Serbia
• Maintains all existing pharmaceutical product and medical devices marketing authorizations and gain regulatory authority approval for the variations of these authorizations
• Makes review of promotional/non-promotional materials for assigned medicinal products and medical devices
• Acts as a coordinator and lead the labelling procedure for Serbia
• Works with the area regulatory team to advocate for the affiliate's strategy objectives
• Engages on cross-functional teams to support business of the company including involvement in planning for and execution of product launches, acquisitions and divestitures
• Monitors emerging legislation and guidance in the national/ EU level and contribute to ensuring company-level awareness and compliance (where appropriate)
• Ensures regulatory compliance and cooperate with pharmacovigilance and quality assurance
• Working with local regulatory authorities, to ensure optimal outcomes for patients and the company’s objectives
• Supports CTA submissions
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The successful applicant has:

• Pharmacy or life-sciences degree (or equivalent)
• 3 to 5 years of experience within regulatory affairs in Serbia – work with medical devices would be considered an advantage
• Presentation and interpersonal communication skills
• High efficiency in English (verbal and written), computer skills and system management

Only selected candidates will be contacted.