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
Qualifications
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.
