Senior Manager Regulatory

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Job Title: Senior Manager - Regulatory

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Job Type: Full-Time

• Ensure the maintaining of registration renewal and new registration with local regulatory authorities and drug safety support for products in Sri Lanka. Secure the growth of business in Sri-Lanka
• To secure regulatory approvals of new products /existing products /renewals in due time, for Reckitt products in the affiliates
• Preparation and review of documents to be submitted to the regulatory authorities.
• Provide feedback to the development of new regulations, policies, and guidelines
• Liaise with a rang of colleagues from country regulatory, marketing, R&D, Supply, and global/regional regulatory teams.
• Ensure the registration and regulatory compliance of marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.
• Coordinate with GRA to collect documents for  submission portal for all 7 categories. (Medicine/medical device/cosmetics/biocides/pesticide/Ayurvedic/ Nutrition)
• Coordinate with GRA to request documents for variation updates.
• Ensure the maintenance of GRAIS and PCS systems in compliance with global & Local.
  
  Requirements
  
  • To secure regulatory approvals of new products /cosmetics and devices in due time, for products in the affiliates
  • Handling the role of 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 on-going, 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 obtain registration) under pest and disinfectant categories.
    
  Regulatory Requirements:
  
  • Maintaining a database of local regulatory requirements.
  • Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues and new regulatory updates.
    
    
  Regulatory and Safety Advice
  
  • Providing regulatory and product compliance expertise in the area of advertising, label claims
  • Protecting key brand and product claims using regulatory expertise.
  • Providing technical support and advice to respond to consumer and legal inquiries, regulatory issues for our products marketed in Sri-Lanka
  • Communicating with Global Regulatory, Safety, and Local Quality and supply on:
  • Potentially serious product issues / product complaints. For serious product issues, ensuring appropriate communication with local Regulatory Authorities after discussion with General Manager, Head of Regulatory & Medical Affairs South Asia, Global QA, Regional Quality Management, and other key stakeholders as necessary.
    
    
  Communication:
  
  • Constructively challenging proposed business initiatives if regulatory, quality / GMP risks are identified and communicate to General Manager, category head Regulatory affairs R&D, Marketing team and quality.
    
  
  
  PROFESSIONAL QUALIFICATIONS/ EXPERIENCE
  
  • Qualified pharmacist registered under Sri Lanka Medical Council
  • Language skills: Fair knowledge in English and fluent in Sinhala
  • 13 years of experience in the regulated healthcare care, medical device and cosmetics
  • Solutions/plans for situational incidents to avoid/minimize impact to the business.
  • Ability to work in a computer literate environment.
  • Loyal and Punctuality
  • Ability to work under pressure and meet strict deadline.
  • Very strong ability to organize work.
  • Hardworking & willing to learn.
  • Ability to grasp new ideas, concepts & methods.
    
    Ready to take your career to new heights?
    
    We're InTalent Asia, your go-to recruitment partner in Sri Lanka, and we've got an exciting opportunity for you!
    
    Our client in the Hygiene and Health is on the lookout for a dynamic individual to fill the role of Senior Manager Regulatory.
    
    At InTalent Asia, we're not just recruiters; we're here to architect your career success. Join us in the journey of matching your skills with unparalleled opportunities.
    
    Apply now and see how you can be the perfect fit for this exclusive position!
    
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