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
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.
Workforce
Workforce Human Resource je regionalna HR kompanija koja posluje u zemljama Adriatic regije. Imamo preko 20 godina iskustva u HR industiji gde svakodnevno podržavamo preko 500 klijenata i preko 5.000 saradnika. Naša rešenja kreirana su prema vašim potrebama, bilo da tražite posao ili ste poslodavac, bilo da vam treba 1 ili 1.000 zaposlenih. Pružamo podršku u regrutaciji, u zapošljavanju, oblasti radnog prava i HR konsaltinga, obračunu zarada, outsourcingu procesa regrutacije i onsite menadžmenta.…