Executive Regulatory
2 days ago
Job Description- Sr Executive / Executive – Regulatory
Department : Regulatory Affairs
Reporting to : GM - SCM Location: Mumbai, India
Job Summary : We are seeking a knowledgeable and detail-oriented Executive / Senior Executive
– Regulatory & Legal to oversee regulatory compliance, manage legal documentation, and ensure
the company adheres to all relevant laws and regulations. The ideal candidate will have a strong
understanding of corporate legal frameworks, regulatory processes, and excellent drafting and
communication skills. Regulatory Affairs – Key Responsibilities:
● License Management:
○ Timely renewal and modification of product and site licenses. ○ Liaise with relevant authorities (e.g., FSSAI & FDA) for queries and status updates. ● Product Registrations & Applications:
○ Prepare, compile, and submit dossiers (Form I) for new product applications in
FSSAI and timely respond to its queries. ○ Ensure compliance with regulatory requirements for both domestic and international
markets. ● NPD :
○ Provide regulatory support during formulation & development of New Product (NPD). ○ Oversee regulatory clearance procedures for new product launches. ○ Review product artworks, labeling, and claims to ensure alignment with current
regulations. ○ Prepare and maintain Product Information Files (PiF) as per statutory requirements. ○ Ensure accurate and timely data entry and documentation for all regulatory activities. ● Cross-functional team interaction & Internal Stake holder Coordination:
○ Support regulatory activities for import-related documentation and compliance. ○ Give Clearance on ingredient approval as per the regulatory requirements. ○ Coordinate with cross-functional teams (R&D, Quality, Technical, Marketing, Manufacturing Site) for timely clearances and troubleshooting. ○ Update, train and guide all the teams / internal stakeholders for recent regulatory
updates as per market. ○ Collaborate for timely product clearances, artwork finalization, and regulatory
troubleshooting. Legal – Key Responsibilities:
● Contract Drafting & Review:
■ Draft, review, and negotiate various legal agreements including:
■ Non-Disclosure Agreements (NDAs)
■ Distribution Agreements
■ Trademark Licensing Agreements (TMLA)
■ Tri-Party Agreements (P2P)
■ Raw Material Supply & Trademark Usage Agreements
● Trademark & IP Support:
■ Coordinate with legal counsel for trademark registration, renewals, and
enforcement. ■ Handle trademark-related notices or disputes.
● Legal Compliance & Notices:
■ Manage and respond to legal notices and ensure timely resolution in
coordination with senior legal advisors. ■ Maintain a database of ongoing legal matters and agreements. Cross-Functional Collaboration:
● With Supply Chain Management (SCM):
■ Coordinate on regulatory requirements for sourcing, imports, and vendor
agreements. ■ Collaborate for timely product clearances, artwork finalization, and regulatory
troubleshooting. ● Internal Communication:
Act as a bridge between regulatory, legal, and commercial teams to
ensure smooth compliance workflows. Key Skills & Competencies:
● Strong knowledge of Indian regulatory frameworks (FSSAI, Drugs & Cosmetics Act, etc.)
● Proficiency in legal document drafting and contract management
● Excellent communication and coordination skills
● Attention to detail with a compliance-oriented mindset
● Ability to manage multiple projects and deadlines simultaneously
Qualification : Science Graduate / Post Graduate Diploma in Regulatory Affairs ( Preferable)
Experience : Min 1 year
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