Regulatory Affairs Lead Full Time NEW

Role:

The Regulatory Affairs Lead is responsible for ensuring the product registrations/approvals, market authorizations, and sustained compliance to all applicable external regulations for the personal care products (Cosmetics and OTC drugs) across all makets of VVF’s interest (mainly, USA, UAE, India and SEA). This role ensures that all applicable regulatory requirements, frameworks, standards & documentation are consistently met for the new product introductions as well as for ongoing product lifecycle management, across the target markets. The successful candidate will serve as a key liaison between VVF, its customers and the regulatory agencies (such as FDA, Ministry of Health and other market-specific licensing authorities), on all matters of regulatory compliance.

Job Description:

1. Prepare, review and submit the regulatory dossiers for product registrations/approvals to the relevant regulatory authorities (US FDA, CDSCO, etc.), to support new product launches.

2. Prepare, review and file variations, in cases of significant changes, to ensure sustained compliance to the applicable regulations during the product lifecycle.

3. Provide regulatory guidance to R&D (Product, Process & Package Development) during the new product/process/package development and/or revisions thereafter.

4. Review and approve the formula proposals (ingredients and their levels) by R&D from the applicable regulations perspective.

5. Be the point person for all regulatory authorities as well as for all external customers on matters related to regulations.

6. Review and approve rrtworks (text & graphics of all printed packaging materials) for its compliance to applicable regulations.

7. Review and approve the product claims by assessing its acceptance by regulations and the ability to scientifically substantiate, in case it’s challenged.

8. Regularly monitor the evolving regulations for its impact on our scope of products and guide the appropriate functions for proactive compliance.

9. Manage product renewals, licence approvals/renewals, facility and people approvals, as applicable.

10. Be the custodian of regulatory dossiers, product approvals, facility licenses/approvals, people approvals, variations, post-approval changes and any liaison with the regulatory authorities.

11. Partner with Manufacturing and Quality to drive regulatory compliance, to ensure health authority inspection readiness at all times.

12. Be a part of the internal audit team to identify potential regulatory risks and work collaboratively to implement the mitigation plan.

Exp – 10+ years of experience in Regulatory Affairs function of a Pharmaceutical or Consumer Healthcare company, with at least 3 years in a leadership role.