Infinium Pharmachem Limited is a leading manufacturer of pharmaceutical APIs, & intermediates serving clients worldwide. Established in 2003.
We are looking for enthusiastic and well experienced candidate for post of Regulatory Affairs Officer.
Job Description – Regulatory Affairs Officer
Company: Infinium Pharmachem Limited
Location: Sojitra, Anand, Gujarat (Factory)
Experience: 0-1 years in Regulatory Affairs
Qualification: M.Pharm in Regulatory Affairs
Job 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.
Benefits:
- Food provided
- Provident Fund
Work Location: In person
