Manager International Regulatory Application Research

Position Title: Manager International Regulatory

Department: R & D Application Research
Reporting: Director Technical 
Qualification: M Sc Agri, PGDM EXIM Or Any Relevant

Location - Mumbai (Navi Mumbai)

Purpose of the Role:

To manage and ensure compliance with international regulatory requirements for product registration, documentation, and submissions, enabling market access across global regions while adhering to local laws and industry standards.

Role & Responsibilities:

1. Prepare, draft, and submit regulatory dossiers and applications for product registration across international markets within defined timelines; ensure proper follow-up and coordination with concerned teams.

2. Liaise with external consultants, government bodies, and regulatory agencies to expedite approvals and resolve queries efficiently.

3. Collaborate with internal teams including R&D, Quality, Manufacturing, and Supply Chain to gather necessary data for dossiers, technical documents, and compliance reports.

4. Support the set-up of new manufacturing and R&D units abroad by preparing regulatory
 documentation, engaging with local authorities, and ensuring compliance with global standards.

5. Manage state-wise and country-specific licensing requirements, including Provisional Registrations,
 Standardization of Specifications, Form G2/G3 filings, and permissions across multiple regions.

6. Handle Show Cause Notices, regulatory inspections, and post-registration issues, preparing replies
 and attending hearings on behalf of the organization.

7. Track changes in international regulations, ensuring updates are communicated and compliance
 strategies are adjusted accordingly.

8. Maintain regulatory databases, submission trackers, and audit-ready documentation in line with
 industry best practices.

9. Provide guidance and training to internal teams on regulatory requirements and submission procedures.

Managerial Business Managing Others Managing Self

• Business Acumen
  
• Customer Centric
  
• Collaborate Seamlessly
  
• Nurture Talent
  
• Communicate to Impact
  
• Drive Results
  
  
  Functional Competencies
  

1. Interpretation and Analysis of the data.

2. Product Development

3. Validation of data

4. Analytical Skills

5. Presentation Skills.

Role Challenges:

The role involves navigating complex and evolving international regulations, managing tight timelines across global teams, ensuring accurate documentation, and balancing compliance requirements with business objectives in a dynamic and high-pressure environment.