Overview
Location: Chennai
We are seeking a Regulatory Affairs professional to manage regulatory submissions, ensure compliance with applicable guidelines, and support product registrations. The role requires strong documentation skills and familiarity with regulatory standards such as Good Manufacturing Practice .
Responsibilities
- Manages regulatory projects registrations, including preparation of registration dossier, submission and follow up with regulatory authorities.
- Maintains and renews existing product licenses
- Keeps up to date with changes in regulatory legislation and guidelines in Asia Pacific countries assigned and sharing the information within the organization
- Interprets and provides regulatory guidance to cross functional team including manufacturers, scientists and marketing and sales colleagues
- Reviews labels, marketing materials for accuracy and regulations compliance
- Manages and support regulatory operational work assignments
- Responds to customers requests and resolves issues regarding regulations and compliance matters
- Supports the RA functional Head in various other activities as assigned
- Studies and interprets related scientific and legal documents for regulatory applications
- Writes comprehensible and clear product information leaflets
- Offers advice about company policies, practices and systems
- Liaises and negotiates with regulatory authorities for registration applications
- Ensures that company's Intellectual properties are protected.
Qualifications
Degree/Diploma in Science (Animal Nutrition /Feed Science / Aquiculture Specialty / Biochemistry/ Microbiology/Food Science/ Biotechnology/ biomedical science/) with 3 years of experience.
