Vice President Regulatory Affairs

One of our esteemed Pharma client based at Mumbai is looking for AVP/VP Regulatory Affairs for US Markets. Job Description is given below;

Industry:

Location: Mumbai

Experience:

Qualification:

Role Overview

Vice President – Regulatory Affairs

Key Responsibilities

• Regulatory Leadership:

  Formulate and execute global regulatory strategies, with a strong focus on

  ANDA filings, submissions, and approvals

  for the USFDA market.

• Regulatory Submissions:

  Lead the preparation, review, and submission of high-quality dossiers (ANDA) ensuring compliance with USFDA and ICH guidelines.

• Compliance & Quality:

  Ensure regulatory compliance across product development, manufacturing, and post-approval lifecycle management.

• Team Leadership:

  Build, mentor, and lead a high-performing regulatory team, fostering collaboration with cross-functional departments including R&D, Quality, Manufacturing, and Commercial.

• Stakeholder Management:

  Act as the primary liaison with regulatory authorities (USFDA and other international agencies), effectively managing interactions, inspections, and queries.

• Regulatory Intelligence:

  Monitor changes in global regulatory landscapes, provide strategic insights, and ensure organizational readiness for evolving guidelines.

• Lifecycle Management:

  Oversee regulatory activities for marketed products, including supplements, amendments, labeling updates, and annual reports.

• Cross-Functional Collaboration:

  Partner with senior leadership to align regulatory strategies with overall business objectives and product pipeline priorities.

Candidate Profile

• Education:

  M.Pharm / Ph.D. in Pharmaceutical Sciences or related field.

• Experience:

  Minimum 20 years in

  Regulatory Affairs

  , with a strong track record of

  ANDA filings and approvals for the US market

  .

• Industry Background:

  Proven experience in reputed, research-driven pharmaceutical organizations.

• Expertise:

• Comprehensive knowledge of

  USFDA regulatory requirements

  .
• Strong exposure to

  ANDA/NDA submissions,

• Familiarity with global regulatory environments (USA markets preferred).

• Leadership Skills:

  Demonstrated ability to lead and mentor large regulatory teams, influence senior stakeholders, and represent the organization with regulatory bodies.

• Soft Skills:

  Strategic thinker, excellent communicator, detail-oriented, with strong problem-solving and decision-making abilities.

In case you are looking for this exciting opportunity, you can reach me on pgarg@uppl.in along with your latest cv and location preferences.

Regards

Piyush Garg

Utkarsh Placement Pvt Ltd

Vadodara

Mail Id-pgarg@uppl.in

Website-www.uppl.in