Vice President Regulatory Affairs

2 days ago

Mumbai, Maharashtra, India Utkarsh Placement Pvt. Ltd. Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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

Job Description – Vice President (VP) Regulatory Affairs

Industry:
Pharmaceutical Manufacturing

Location: Mumbai

Experience:
20+ years

Qualification:
BPharm/M.Pharm / Ph.D. in Pharmaceutical Sciences

Role Overview

We are seeking a highly accomplished
Vice President – Regulatory Affairs
to lead the global regulatory strategy and operations for a reputed pharmaceutical organization. The incumbent will play a critical leadership role in ensuring successful
ANDA filings, approvals, and lifecycle management
for the
US market
, while also driving regulatory excellence across other geographies.

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 along with your latest cv and location preferences.

Regards

Piyush Garg

Utkarsh Placement Pvt Ltd

Vadodara

Mail Id-

Website-

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