M.J. Biopharm Pvt. Ltd. is a leading name in the pharmaceutical industry, known for its high-quality formulations and commitment to global health standards. With a robust portfolio of pharmaceutical products, the company focuses on innovation, excellence, and meeting international regulatory standards.
Job Responsibilities
As a Regulatory Affairs Officer, you will play a critical role in ensuring compliance with global regulatory requirements. Your responsibilities will include:
- Exploring and updating guidelines necessary for dossier compilation for ROW (Rest of World) and regulated markets.
- Preparing, compiling, reviewing, and submitting pharmaceutical dossiers as per ICH (International Conference on Harmonization) and country-specific guidelines in formats like CTD, ACTD, and others.
- Collaborating with internal teams to obtain and review quality data for dossier preparation.
- Coordinating and sending samples for registration purposes across different countries.
- Managing health authority queries and preparing appropriate responses.
- Assisting with national and international tender documentation.
- Maintaining a comprehensive product database and dossier archive.
- Supporting COPP (Certificate of Pharmaceutical Product) applications.
Qualifications and Skills Required
To succeed in this role, candidates must meet the following criteria:
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- Educational Background: A degree in pharmacy or a related field with a strong formulation background.
- Experience: 3-5 years in regulatory affairs within the pharmaceutical industry.
- Technical Skills:
- Proficiency in dossier preparation for ROW and regulated markets.
- Knowledge of ICH, CTD, and ACTD guidelines.
- Experience in responding to health authority queries and document management.
- Soft Skills:
- Excellent communication and coordination abilities.
- Strong attention to detail and organizational skills.
How to Apply
Interested candidates are encouraged to take the following steps:
- Prepare an updated resume highlighting your experience in regulatory affairs and your formulation background.
- Email your CV to shital@mjbiopharm.com or janhavi.shedekar@mjbiopharm.com.
