Currently we are looking for a Regulatory Affairs Manager to join our team!
The Regulatory Affairs Manager is responsible for the development and implementation of a successful regulatory strategy for our clients’ products (prescription medicines, essential similar products, OTCs, Cosmetics and Food Supplements).
- Keeping up to date with local and EU legislation, guidelines and practices
- Preparing and submitting New Drug Applications (CTD) through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures (MAA)
- Maintenance of Marketing Authorization Applications (Variations and Renewals) abiding to post approval commitments, as well as handling of withdrawals and transfers of Marketing Authorizations
- Reviewing of artworks and promotional material to ensure regulatory compliance
- Adaptation and translation of Product Information (SmPC, labelling & PIL) in compliance with the EU and local legislation.
- Supporting pricing and reimbursement activities
- Registration of medical devices to the National/European database and preparation/maintenance of technical dossier for CE mark
- Providing regulatory intelligence to our clients by reviewing and evaluating marketing information, regulations, guidelines, procedures etc.
- Liaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and our customers
- University degree in life sciences, pharmacology or chemistry
- At least 3 years of previous demonstrated experience in the regulatory field
- Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
- IT literacy (MS Windows, MS Office, Internet Use)
- Solid understanding of the drug development process, pharmaceutical legislation and scientific matters
- Ability to interact professionally with customers and work effectively within a team
- Strong strategic thinking, analytical and problem-solving skills
- Excellent organizational, prioritizing and communication skills
- Ability to manage multiple and varied tasks with attention to detail
- Effective time management to ensure project deadlines are met
- Ability to work independently with regular oversight