Identify and analyse regulatory requirements for different countries; assist in product registration.
Periodically track worldwide regulatory developments, provide timely alerts on regulatory changes, and ensure adherence to compliance standards.
Prepare DMF/dossiers for regulatory submissions (India, Europe, US, Canada, Australia & ROW); handle application filing, tracking status, and liaising with regulatory authorities.
Coordinate with internal stakeholders to gather essential technical information for dossier preparation.
Assist in Product life cycle management (maintenance, renewal of product registration) & compliance related activities.
Handle customer queries related to regulatory compliance, technical information.

Preferred candidate profile

Good scientific knowledge, Good analytical and problem-solving abilities.
Excellent written and verbal communication skills, ability to write high quality submission documents, Proficient in MS- Word and MS Excel.
Expertise in a regulatory affairs area, acquainted with Indian, US and European regulations for food, animal feed, probiotics and nutraceuticals, familiarity with enzyme/ protein related databases.
Experienced in DMF/ dossier writing OR journal article writing.
Ability to multitask and work in a fast-paced environment.

Experience Required

2-3 years of experience in regulatory affairs, preferably in the food/nutraceutical sector.
M.Sc./Ph.D. in Biotechnology, Microbiology, Life Science, Food Science, Biochemistry

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