1. To prepare technical documents for dossier and product approval.
2. To gather, evaluate, organize, manage and collate the regulatory information in a variety of formats.
3. To ensure, document and monitor product compliance with regulations set by FSSAI.
4. To keep updated with changes in regulatory legislation and guidelines and implement the same in system.
5. To analyze complicated regulatory information and circulate within the concern departments.
6. To Offer advice about regulations, company policies, practices and systems
7. To Outline requirements for Labelling, storage and packaging
8. To write comprehensible, user-friendly, clear regulatory product information
9. To ensure regulatory dossier/ document submissions meet strict deadlines
Key skills for regulatory affairs officers:-
Time management skills
Report drafting skills.
An understanding of relevant regulations, regulatory protocol is also necessary.
Salary: INR 1,75,000 - 3,50,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time