Regulatory Affairs Officer (M.Pharm)

Roles & Responsibilities:
• Prepare and submit Drug Master Files (DMFs) for the USA and EU.
• Ensure compliance with regulatory guidelines and filing procedures.
• Maintain and update regulatory documentation for accreditation processes.
• Coordinate with internal teams to gather required data for submissions.
• Liaise with regulatory agencies to address queries and ensure timely approvals.
• Monitor changes in global regulatory requirements and update documentation accordingly.
• Support audits and inspections by regulatory authorities.

Qualification:
• M.Pharm in Regulatory Affairs.

Experience:
• 1-2 years in Regulatory Affairs.

Skills:
• Strong knowledge of DMFs and regulatory filing procedures.
• Familiarity with global regulatory guidelines (FDA, EMA).
• Excellent documentation, organizational, and problem-solving skills.
• Ability to work collaboratively with cross-functional teams.
• Strong communication skills.

About the Organization:
Infinium Pharmachem Limited, established in 2003, is a leading manufacturer of pharmaceutical intermediates and APIs serving clients worldwide. The company focuses on quality, compliance, and innovation, delivering high-standard products to meet global regulatory requirements and supporting the pharmaceutical industry with reliable and efficient solutions.