Regulatory Affairs

12 hours ago


Bengaluru Bangalore Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full time
Summary:
The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.

Roles and Responsibilities:
  • Regulatory Submissions: Prepare and submit regulatory documents for product approvals and amendments.
  • Compliance Management: Ensure ongoing compliance with regulatory requirements.
  • Regulatory Strategy: Develop strategies to achieve and maintain product approvals.
  • Documentation: Maintain accurate and complete regulatory documentation.
  • Liaison: Communicate with regulatory agencies and respond to queries.
  • Risk Management: Identify and mitigate regulatory risks.
  • Collaboration: Work with R&D, QA, Manufacturing, and Marketing teams.
  • Regulatory Intelligence: Stay updated on regulatory changes and trends.
Qualifications Required:
  • Education: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field. A Master's or certification in Regulatory Affairs is preferred.
  • Experience: 3-5 years in regulatory affairs within the pharmaceutical industry.
  • Knowledge: Familiarity with FDA, EMA, ICH guidelines, and product development processes.
Skills Needed:
  • Analytical Skills: Interpret and apply regulatory requirements.
  • Attention to Detail: Accuracy in regulatory documentation.
  • Communication: Effective interaction with regulatory agencies and teams.
  • Problem-Solving: Address regulatory issues and challenges.
  • Organizational Skills: Manage multiple projects and deadlines.
  • Technical Skills: Proficiency in regulatory software.
  • Interpersonal Skills: Collaborate with cross-functional teams and regulatory authorities.


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