Manager - Regulatory Affairs - FMCG

Job Description :

1. Provide strategic input and technical guidance on regulatory requirements to development

2. To keep track of changes in regulation, changes in standards, labeling, FDA approval process, weights & measures act, Packaged commodities order and interpret them.

3. Identify issues early in the submission preparation process that could impact product launch

4. Monitor impact of changing regulations. Assess regulatory impact and risk Compile and synthesize relevant data to complete regulatory submissions.

5. Advise management and stakeholders on complex regulatory issues requiring innovative solutions

6. Formulate company procedures to respond to regulatory authority queries.

7. To checking of all artworks of back of pack labels and other products communications.

8. Review and approve claim support data.

9. Monitor and submit applicable reports and responses to regulatory authorities.

10. Negotiate and interact with regulatory authorities during the product application review process to ensure approval.

11. Manage activities such as audits, regulatory agency inspections, or product recalls.

12. Manage Cos me to vigilance Activity to track and manage product associated events.

13. Advance the organization's position by actively participating and taking leadership roles in professional associations ,industry and trade groups and appropriate standards organizations.

Qualification & Experience :

1. PG in science (chemistry, biology, environment science, pharmacy, cosmetics technology etc) / Pharmacy.

2. 5 to 7 years- Experience in working in Cosmetics. About 2 years of Experience in industrial product/process development would be desirable.

3. Sound knowledge of Drugs & Cosmetics Act & Rules, BIS, REACH, ISO and other related regulations.

4. Awareness of Government structures and functioning like FDA, CDSCO, NBA, Relevant Ministries.

5. Knowledge about Domestic regulatory markets International regulatory markets.

6. External regulatory environment affecting the industry.