Mankind Pharma is a leading pharmaceutical company known for its commitment to providing high-quality medicines at affordable prices. With a strong presence in both domestic and international markets, the company focuses on research and innovation to enhance healthcare solutions. Mankind Pharma specializes in various therapeutic segments, including cardiology, neurology, gastroenterology, and respiratory medicines, making it a reputed name in the pharmaceutical industry.
Responsibilities in Job
The RA/RS – Regulatory Affairs position at Mankind Pharma entails various crucial responsibilities, including:
- Preparation & Submission of Drug Master Files (DMFs): Developing and submitting new DMFs for drug substances across different countries in compliance with business requirements.
- Electronic Submission of DMFs: Preparing and submitting DMFs in electronic format (eCTD) per regulatory guidelines.
- Providing Technical & Regulatory Support: Assisting sales, marketing teams, and external customers with technical data packages and regulatory documentation.
- Reviewing R&D Generated Documents: Examining quality plans, raw material specifications, in-process and final drug substance documentation.
- Reviewing Plant-Generated Documents: Ensuring compliance in areas such as change controls, executed batch production records (BPR), protocols, stability data, and certificate of analysis (COAs).
- Inter-Departmental Support: Collaborating with R&D and plant teams to facilitate regulatory compliance.
- Other Assigned Duties: Executing additional regulatory responsibilities as assigned by the Reporting Manager and Head of Regulatory Affairs.
Qualifications
Candidates interested in the RA/RS – Regulatory Affairs role should meet the following qualifications:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or a related field.
- 2 to 5 years of experience in regulatory affairs within the pharmaceutical industry.
- Knowledge of eCTD submissions, DMF preparation, and global regulatory guidelines.
Skills
The ideal candidate should possess:
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- Strong understanding of regulatory requirements and documentation.
- Proficiency in eCTD and drug master file (DMF) submissions.
- Excellent communication and coordination skills to liaise with cross-functional teams.
- Analytical skills to review and assess regulatory documents.
- Ability to work under tight deadlines and manage multiple projects efficiently.
