Infinium Pharmachem Limited is a leading manufacturer of pharmaceutical APIs and 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
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.

Advantages:

- Food provided
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Officer (India)
🏢 Infinium Pharmachem
📍 India