Russia's leading innovative biotechnology company BIOCAD has opened Head of International Drug Regulatory Affairs Division.
Responsibilities:
- Management of regulatory affairs team.
- organization of registration processes for medicines on international markets.
- Development of International DRA plans and strategies to support the fastest registration time for Biocad products on international markets.
- Buildup of the successful intercommunion between internal divisions.
- Development and approval of standard operating procedures.
Requirements:
- Higher education (pharmaceutical, chemical, biotech).
- Experience on the International Drug Regulatory Affairs (generics, biologics/biosimilars, original products).
- Team management experience.
- Hands -on knowledge of the requirements for the registration of medicinal products in ASEAN, MENA, Africa, Europe, the USA, of other regions.
- Broad hands-on experience of the registration all over the countries, existence of MA approvals as the result of the past experience.
- Excellent communication skills, well-organized.
- Be initiative and good team player as well, open-minded and resulted-oriented.
- Fluent English (verbal and writing skills).
- Russian speaking applicants.
We offer:
- Job in an innovative biotechnology company with original medicines.
- An opportunity to develop expertise in international drug regulatory affairs.
- Competitive salary based on market benchmark.
- Voluntary health insurance after passing the probationary period.
- Opportunities for professional and career development.