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Oxford Global Resources is a leading consulting services division, seeking an experienced Regulatory Affairs Specialist to support top pharma companies. Key Responsibilities:
Oversee and manage regulatory processes for international marketing authorizations (MAs) of pharmaceutical products, including those of the client and its subsidiaries. Ensure maintenance of existing authorizations and obtain new ones as needed.
Manage lifecycle of pharmaceutical product MAs by preparing and organizing applications, dossiers for new authorizations, and submitting variations or extensions. Provide guidance on regulatory strategies for new international registrations, certifications, and MAs.
Liaise with regulatory authorities, partners, and external service providers to ensure smooth approval processes. Coordinate internal communication related to planned approval activities and post-approval processes, in line with applicable drug laws, EU regulations, and GMP guidelines.
Requirements, Skills, and Qualifications:
- Bachelor's degree in Life Sciences or a related field
- Fluency in English for business communication
- Minimum of 5 years of experience in International Regulatory Affairs within the pharmaceutical industry, ideally at a global level
- In-depth knowledge of international registration processes and pharmaceutical legislation across key global markets
- Proven ability to collaborate effectively with partners and regulatory agencies, securing approvals and managing product lifecycle across various regions