Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs
Posted on :
23-12-2024
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Job Description
We're a leading recruitment company in Sri Lanka looking for a Manager Regulatory Affairs for a wellreputed MNC/FMCG company located in Colombo. This position requires ensuring the maintenance of registration renewal and new registration with local regulatory authorities and drug safety support for the company.
Key Responsibilities:
Key Responsibilities:
- To secure regulatory approvals of new products /existing products /renewals in due time.
- Prepare and review documents to be submitted to the regulatory authorities.
- Provide feedback on the development of new regulations policies and guidelines.
- Liaise with a range of colleagues from country regulatory marketing R&D Supply and global/regional regulatory teams.
- Coordinate with GRA to collect documents for NMRA submission for 7 categories. (Medicine/medical device/cosmetics/biocides/pesticide/Ayurvedic/ Nutrition)
- Ensure the maintenance of GRAIS and PCS systems in compliance with global & Local requirements.
- Handling the role of the Drug Safety Officer to ensure that the local National Business Unit (NBU) is coordinated with all internal and external regulations ensuring that regulation changes are.
- Implemented internally and externally Conduct the meetings with GRA to update latest regulations.
- Responsible for completing key tasks in the provision of safety services and vigilance to facilitate and support the ongoing oversight of consumer safety marketing and maintenance of licenses for medicinal products medical devices and cosmetics.
- To obtain Ayurvedic registration and approval for the TV commercials.
- Handling ROP (registrar of pesticide) registration (dossier perpetration/renewal submission and obtaining registration) under pest and disinfectant categories.
Qualifications:
- Qualified pharmacist registered under Sri Lanka Medical Council
- Language Skills: Fair knowledge in English and fluent in Sinhala
- 13 years of experience in regulated healthcare care medical devices and cosmetics
- Solutions/plans for situational incidents to avoid/minimize the impact on the business.
Employment Type
Full Time
Key Skills
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