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Regulatory Operations Strategist

Full-Time Tamil Nadu, India
Health & Biotech
Health & Biotech
26 June 2024
  • Coordinate factory regulatory change assessments with the receiving markets and any other assessment the supply factories require if they have regulatory registration or registration change control concerns or questions
  • First point of contact for technical (e.g.ingredient compliance, support for registration) market support requests within their region
  • May be involved in coordinating document generation to ensure raw material compliance
  • Follows-up key ingredient authorizations within their region
  • Works with suppliers or internal stakeholders or consultants to prepare necessary dossiers for new ingredient authorizations (e.g. HMOs, probiotics, etc.)
  • Maintains a global tracker of authorization status of key ingredients globally (ingredient registration DB)
  • Coordinate, consolidate and maintain up to date requirements and timelines for ingredients registrations
  • Supports MRM team to manage ongoing ingredient issues
  • May be involved in ingredient compliance workflow for standard ingredients
  • Act as back up for executing the product registration plan for the markets/ region in case main responsible team member is not available.
  • Act as back-up for reg ops strategist out of Tuas to coordinate between market, factory and market RSA and other functions to provide registration dossiers on-time, Right First Time to the markets
  • Bachelors Degree level in Food Science or Pharmaceutical Science or related discipline
  • 5+ year’s experience in regulatory affairs or related work experience. Pharma or supplements experience helpful.
  • Project Management experience demonstrating ability to successfully lead complex regulatory project and overcome obstacles in difficult environment.
  • Knowledge of food / Pharma Registration and submission process in the region of focus
  • Clear understanding of GMP and Food Safety standards required for infant formula, Health Science products and maternal product range.
  • Proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully.
  • Good knowledge of registration process for raw materials and ingredients.
  • Good knowledge and insight in raw materials manufacturing and quality process.
  • Capacity to manage workload through efficiency, prioritization and managing stakeholder expectations.


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