The Role
Responsible for regulatory support across the product life cycle, ensuring compliance with regulations, maintaining documentation, and interacting with regulatory authorities.
Summary Generated by Built In
The role is accountable for ensuring the appropriate licensing and maintenance of assigned products and development projects in line with company business objectives, relevant regulatory requirements and internal and external standards.
Job Responsibilities
- Responsible for the provision of regulatory support for assigned products across the full life cycle, from pre-launch, launch, maintenance, discontinuation and divestment
- Follows approval strategy and works proactively to ensure project completion
- Performs routine regulatory activities under minimum supervision (i.e. dossier maintenance/renewals/variations/CTD sequence preparation)
- Evaluates/Prepares Module 1 of the technical documentation required for variations of pharmaceutical products
- Maintains an up to date and developing knowledge of regulatory affairs legislation
- Prepares and reviews packaging materials for product launch and/or compliance with legislation and guidelines, for different type of products
- Interacts directly with regulatory authorities on defined matters including negotiating regarding marketing authorizations, variations and renewals
- Participates in regulatory compliance review projects/inspections
- Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
Requirements
- BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
- 3-5 years Regulatory Affairs experience in a pharmaceutical company
- Excellent command of the Greek and English language (written and spoken)
- Strong computer literacy
Skills Required
- BSc in a relevant area
- 3-5 years Regulatory Affairs experience in a pharmaceutical company
- Excellent command of the Greek and English language (written and spoken)
- Strong computer literacy
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The Company
What We Do
Lavipharm SA is a Greek pharmaceutical company that develops, manufactures, markets, and distributes pharmaceutical, cosmetic, veterinary, and consumer health products. It is recognized for its expertise in Transdermal Drug Delivery Systems (TDDSs) and has a significant international presence.
