For our client, well-known pharmaceutical company based in Poznań we are currently looking for a candidate for a position of Regulatory Specialist.
The key responsibilities are:
- take responsibility for authoring, technical review and associated regulatory activities of CMC Annual Reports ( for NDAs/BLAs/DMFs/DSURs and Brazil ARs) across multiple Rx products and dosage forms,
- provide CMC regulatory advice and guidance to applicable Global Regulatory Affairs (GRA)
personnel, Pharma Supply Chain (PSC), 3rd Party Contract Management and Local Operating Companies in markets in order to produce appropriate CMC components for Annual Reports,
- participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
- manage multiple projects simultaneously,
- communicate regularly with Senior Regulatory Manager to help in identification of any issues with business impact,
- build and maintain good relationships with your internal and external stakeholders.
As ideal Candidate for this role will hold:
- Relevant experience in pharmaceutical industry and regulatory affairs.
- Bachelor’s degree in chemistry, pharmacy or other related science or technical field.
- Fluent Polish and English (both verbal and written).
- Ability to handle multiple tasks to prioritize and schedule work to meet business needs
- Excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
Our client offers:
- Established job in international, well-known pharmaceutical company.
- Opportunity to work in professional team playing crucial role in introducing company portfolio to the market.
- Flexible working hours.