Head of Quality & Regulatory Affairs @ Cadila Pharmaceuticals

Feb 23, 2018

Cadila Pharmaceuticals limited

Location: Dholka(Ahmedabad district)

Designation: Vice-President Quality & Regulatory Affairs

Scope of Role: PAN India

Desired Experience:

  • Should possess at least 18+ years of overall experience in Pharmaceutical Industry in Sales & Marketing in large pharma companies with good business volumes and various brands of both prescription and OTC orientation.
  • The ideal candidate should have spent the last 7-10 years in international marketing of which the last 2-3 years ideally as head of marketing team or senior positions in marketing leading a team of 6-10 PMT personnel.


  • Serve as the key contact for the regulatory agency, notified body and customer audits of the facilities.
  • Develop and Implement efficient and effective regulatory strategies to bring products to market (Domestic & International)
  • Development and Implement strategies for educating the FDA on various aspects of the technology and scientific principles upon which the product system operations.
  • Maintain excellent relationships with regulatory agencies and subcontractors.
  • Prepare and Submit marketing approval applications, Product Certifications, Design Dossiers, International Licenses, etc.
  • Identify relevant quality standards for product development, manufacturing and defining design requirement for domestic and international markets.
  • Ensure the company is in full compliance with regulatory agencies.
  • Promote the development of a facility-wide understanding of the key elements related to the quality system and regulatory compliance requirements.
  • Effectively lead and manage department regulatory and quality personnel.
  • As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
  • Determining the root cause of problems that involve compliance with FDA requirements.
  • Overseeing the corrective and preventive actions for the problems.
  • Conducting Recall.
  • Handling preparation and follow up for FDA/ Regulatory Inspections.
  • Keep a regulatory watch and inform the departments concerned of any regulatory changes.
  • Prepare, review and approve external and Internal reports and others documentation required by regulatory agencies.
  • Identify ways to continuously improve quality and compliance with regulations and company standards, policies, and procedures. K

know more here.


You may be interested

Build your career in Pharmacovigilance
Career Biotech
Career Biotech

Build your career in Pharmacovigilance

admin - May 16, 2018

Build career in Pharmacovigilance

Medical Officer at Sanzyme Biologics- HYD
Career Biotech
Career Biotech

Medical Officer at Sanzyme Biologics- HYD

Career biotech - Apr 25, 2018

Job description Qualifications Medical Doctor (MBBS) with MD (Pharmacology) degree and minimum 2 (two) years of working experience as Medical Advisor in a pharmaceutical / ingredient company.…

Career Biotech

Medical Reviewing Internship in Mumbai at Golden Opportunities Private Limited

Career biotech - Apr 25, 2018

Job description About Golden Opportunities Private Limited One of the popular recruitment firm in Chennai. We are dealing with PAN India location recruitment working for top MNCs.…

Leave a Comment

Your email address will not be published.

Most from this category