Head of Quality & Regulatory Affairs @ Cadila Pharmaceuticals

Feb 23, 2018
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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.

Responsibilities:

  • 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.

 

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