Regulatory Affairs Manager

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and re­defining ‘impossible’. There are so many reasons to join us. But if you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Position: Regulatory Affairs Manager

Division: Pharmaceuticals

Responsibilities:

• Participate in regulatory strategies and operational matters elaboration for related portfolio
• Carry out all regulatory affairs activities
• Prepare product application files based on the documentation provided by GRA in accordance with actual regulations and present the respective national Health Authorities
• Prepare local regulatory documents, layouts of packaging materials, responses to HA requests, monitor the registration process and timely inform all stakeholders about the process
• Monitor Russian rules of registration and quality control of medicinal products, timely inform about changes RA Head and other company departments involved in product portfolio promotion and sales
• Support contacts with Ministry of Health and other authorities and the organizations participating in registration, scientific evaluation and quality testing of medicinal products
• Ensure timely approvals of NDA and variations with optimal labels
• Ensure regulatory compliance for a sustainable life-cycle management together with RA Head: Labeling and CMC changes are performed in accordance with local regulations and relevant SOPs. Participates in development of mock-ups
• Lead current reporting, regularly puts essential regulatory information into global and local databases
• Consult and train Regulatory Affairs Specialists and provide support in Dossier review and all other regulatory activities. Provide regulatory support to other departments. Timely provide them copies of registration certificates and relevant approved documentation for the Company products.

Important for us:

• University degree in natural science (pharmacy, medicine, chemistry or biology)
• Minimum 3 years of work experience in medical products registration
• Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products
• Analytical thinking
• Punctuality and sense of responsibility
• Ability to work under the stress
• Good command of English (both oral and written)
• Advanced user of PC
• Communication skills.

We offer:

• Career in the sustainable international company
• Monthly salary and annual bonus
• Meal allowance, corporate mobile coverage, corporate car
• Health and life insurance
• 35 days paid vacation
• Corporate learning and development program
• Corporate reward and recognition program.