Details of the Organization

Generex takes pride in introducing branded, clinically backed and patented new ingredients to the Indian Pharmaceutical, Nutraceutical and Health Supplement industry.

Details of the Job/Internship

Generex is hiring for the position of Regulatory Affairs Executive to join their office in Mumbai. 

Role and Responsibilities

Regulatory Affairs

1. License & Product Registration

• Ensure timely renewal and modification of product and site licenses (FSSAI, FDA, etc.).
• Coordinate with regulatory bodies to manage application status and resolve queries.
• Prepare and submit Form I dossiers for new product applications and follow up on clarifications.

2. New Product Development (NPD) Support

• Provide regulatory guidance during product formulation and development stages.
• Facilitate regulatory clearance for product launches across domestic and international markets.
• Review packaging artworks, claims, and labels for compliance with applicable regulations.
• Prepare and maintain Product Information Files (PiFs) as required by law.

3. Documentation & Compliance

• Ensure accurate data entry, documentation, and tracking of regulatory activities.
• Approve ingredients and formulations in line with regulatory standards.

4. Cross-functional Coordination

• Collaborate with R&D, Quality, Marketing, Manufacturing, and Technical teams for timely regulatory approvals.
• Provide internal training on regulatory updates and ensure stakeholder awareness.
• Support compliance in import-related activities and documentation.

Legal Affairs

1. Contract Management

• Draft, review, and negotiate a variety of legal agreements, including:
• Non-Disclosure Agreements (NDAs)
• Distribution Agreements
• Trademark Licensing Agreements (TMLAs)
• Tri-party Agreements (P2P)
• Raw Material Supply & Trademark Usage Agreements

2. Intellectual Property Support

• Coordinate with legal counsel for trademark registration, renewals, and enforcement.
• Manage responses to IP-related notices and disputes.

3. Legal Compliance

• Address and respond to legal notices with the support of senior legal advisors.
• Maintain comprehensive records of legal matters, notices, and contracts.

Eligibility

• Bachelor’s/Master’s degree in Law, Pharmacy, Life Sciences, or related field.
• Sound knowledge of FSSAI, FDA regulations, and contract law.
• Strong legal drafting, documentation, and regulatory interpretation skills.
• Excellent coordination and communication skills.
• Detail-oriented with a proactive and collaborative mindset.

Salary/Stipend

Compensation details will be finalized during the interview process with the selected candidate.

Type of Opportunity

Fulltime

Country

India

Address

Mumbai, Maharashtra, India.

Application and Registration Details

After you submit your application, you will receive the next steps in the process via email. Please follow the instructions provided to complete your application.

Incase you find any issue with the application process, please contact: [email protected] 

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We are solely providing this information for dissemination and wish to clarify that we are not affiliated with the organization.