Infinium Pharmachem Limited is a leading manufacturer of pharmaceutical intermediates and APIs, serving clients worldwide. Established in 2003.

Job Description -Regulatory Affairs Officer

Company:Infinium Pharmachem Limited
Location:Sojitra, Anand, Gujarat (Factory)
Experience:1-2 years in Regulatory Affairs
Qualification:M.Pharm in Regulatory Affairs

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.

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

Job Types: Full-time, Permanent, Fresher

Advantages:
- Food provided
- Health insurance
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Officer (Anand)
🏢 Infinium Healthcare
📍 Anand