Regulatory Manager

İşin təsviri

Regulatory Manager:

• Preparing application dossiers to Ministry of Health for new product registration and following up the process
• Filing and storage of all registration relevant documents in the appropriate folders as determined in relevant SOPs
• Demanding information and documents, required for new product registration application from Pfizer Research Centers
• Preparation of the New Drug Application (NDA) and ensuring that all required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process
• Translation/ensuring the translation of required documents into local language
• Follow up of the registration process through MoH
• Notifying related personnel about the registration status
• Communication with Authorities on Product Registration issues as required

In respect of the ideal candidate profile:

• Fluent English
• University degree in Medicine or Pharmacy
• At least minimum 2 years of experience both in the medical services, clinical trials, pharmacovigillance, and regulatory affairs and registration issues in an international pharmaceutical company (or separately)
• Good understanding of the local pharmaceutical market
• Self-developer, fast and keen learner
• Disciplined, well organized, good time management
• Dedicated team player
• High business ethics

[email protected]

Pfizer Represantative Office in Azerbaijan tərəfindən digər vakansiyalar

• Country Customer Marketing
• Country Portfolio Lead (Product Manager)