Regulatory Affairs Manager

Job Title:

Department:

Reporting to:

Job Purpose:

To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing submissions and approvals, and maintaining strong relationships with health authorities to support product launches and lifecycle management.

Key Responsibilities:

Regulatory Strategy & Compliance

• Develop and implement regulatory strategies for new product registrations, renewals, and variations in alignment with business objectives.
  
• Ensure compliance with all applicable national and international regulations (e.g., CDSCO, USFDA, EMA, MHRA, WHO, TGA).
  
• Keep management informed about changing regulations and assess their impact on the company’s products and operations.
  
• Establish and maintain internal regulatory SOPs and documentation systems.
  

Regulatory Submissions

• Oversee the preparation, review, and submission of product dossiers, CTD/eCTD submissions, and other technical documentation.
  
• Manage product registration timelines, ensuring approvals and renewals are obtained within schedule.
  
• Coordinate with R&D, QA/QC, and Production teams for compilation of data required for submissions.
  
• Review and approve product labeling, artworks, and promotional materials for regulatory compliance.
  

Liaison & Communication

• Act as the primary contact with national and international regulatory agencies.
  
• Represent the company during regulatory audits and inspections.
  
• Respond to regulatory queries and deficiency letters in a timely and accurate manner.
  
• Build strong relationships with government agencies and regulatory consultants.
  

Leadership & Team Management

• Lead and mentor the regulatory affairs team to ensure timely execution of projects.
  
• Provide guidance on complex regulatory issues and ensure continuous capability development.
  
• Coordinate with cross-functional departments to align regulatory objectives with business goals.
  

Skills & Competencies:

• Strong understanding of global regulatory frameworks and submission requirements.
  
• Experience with CTD/eCTD dossier preparation and lifecycle management.
  
• Excellent analytical, documentation, and communication skills.
  
• Ability to manage multiple projects under strict timelines.
  
• Leadership and team management skills.
  
• Strategic and detail-oriented approach to problem-solving.
  

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field.
  
• Advanced regulatory certification or postgraduate diploma in Regulatory Affairs (preferred).
  

Experience:

• 7–10 years of experience in Regulatory Affairs, with at least 3 years in a managerial or team leadership role.
  
• Exposure to international regulatory submissions (US, EU, ROW) preferred.
  

Salary Budget: 12 Lacs to 15 Lacs