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Regulatory Affairs Associate-886
2 weeks ago
Responsibilities:
- Contribute to regulatory activities such as pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
- Document and track regulatory submissions and regulatory authority approval.
- Provide ongoing regulatory support to the Regulatory Affairs Specialist and to project teams to meet project objectives.
M. Pharmacy
Experience
2-3 years of EU RA experience
Technical Skills
- Compile regulatory dossiers in accordance with national requirements.
- Provide regulatory support to clients and associate companies.
- Preparation of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
- Provide review of artworks.
- Having experience in working for EU regulatory market.
- Excellent organizational and interpersonal skills.
- Ability to work well within a team.
- Good computer skills and the ability to learn appropriate software.
- Fluency in English (Spoken and Written).
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