Regulatory Affairs Specialist

4 days ago


Vadodara, Gujarat, India Sri Sai Overseas Recruitment Full time

Job Overview

We are seeking a highly skilled Regulatory Affairs professional to contribute to our team's success in Vadodara. The ideal candidate will have a strong background in pharmaceutical regulations, specifically within the industry, and will hold relevant qualifications such as a B.Pharm or M.Pharm degree.

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 is mandatory.
  • 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.


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