Regulatory Affairs Expert

2 days ago


Vadodara, Gujarat, India Lifelancer Full time

About the Role:

We are seeking an experienced Regulatory Affairs professional to join our team in a full-time capacity. The ideal candidate will have a strong background in regulatory affairs, specifically within the pharmaceutical industry.

Key Responsibilities:

  • Ensure compliance with regulatory requirements for pharmaceutical products in target markets
  • Prepare and submit regulatory dossiers and documentation for product approvals
  • Coordinate with cross-functional teams to gather necessary information for regulatory submissions
  • Monitor changes in regulatory policies and update internal procedures accordingly
  • Maintain up-to-date knowledge of global regulatory trends and best practices
  • Act as a point of contact with regulatory bodies and manage communications effectively
  • Review and approve labeling, promotional materials, and product specifications for compliance
  • Provide strategic regulatory guidance to the management team and project stakeholders

Requirements:

  • Proven experience in Regulatory Affairs (Mandatory skill)
  • Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) degree
  • Strong understanding of pharmaceutical regulations and compliance standards
  • Familiarity with regulatory requirements in global markets such as India and the Middle East
  • Excellent communication and negotiation skills for effective liaising with regulatory authorities
  • Attention to detail and strong organizational skills for managing documentation and submissions
  • Ability to work collaboratively with cross-functional teams and external partners
  • Proficient in using regulatory databases and software tools for document management and reporting

Estimate Salary: 40K CTC

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.



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