Regulatory Operations Strategist
Full-Time
Tamil Nadu, India
Health & Biotech
Health & Biotech
Description
- 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.
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