If you are looking to grow your career in regulatory affairs within the biologics and sterile injectables space, this opportunity from M.J. Biopharm Pvt. Ltd. could be the right move. The company is currently hiring for the position of Executive โ Regulatory Affairs at its Pune facility, offering strong exposure to global regulatory submissions and compliance frameworks.
This role is ideal for professionals who want hands-on experience in CMC documentation, CTD/eCTD submissions, and international regulatory standards such as ICH and USFDA guidelines.
Company Overview
M.J. Biopharm Pvt. Ltd. is an emerging pharmaceutical and biotechnology organization focused on biologics, sterile injectables, and advanced drug development. The company is steadily building its presence in global markets by maintaining high standards of quality, innovation, and compliance.
Working here provides an opportunity to contribute to complex pharmaceutical projects and gain exposure to global regulatory environments.
Job Details
Role
Executive โ Regulatory Affairs (CMC)
Location
Pune, Maharashtra
Experience Required
3 to 5 years in Regulatory Affairs (CMC)
Key Responsibilities
- Prepare and review CMC dossiers in CTD/eCTD format (Module 3)
- Support global regulatory submissions and manage deficiency responses
- Coordinate with R&D, QA, QC, and Analytical teams for data compilation
- Ensure compliance with ICH guidelines and international regulatory standards
- Review analytical and characterization data for biologics
- Maintain accurate documentation and ensure data integrity
- Assist in regulatory strategy planning and submission timelines
Eligibility Criteria
Educational Qualification
- M.Pharm
- B.Pharm
- Biotechnology
- Life Sciences
Relevant Specializations
- Regulatory Affairs
- Pharmaceutical Biotechnology
- Drug Regulatory Affairs
- Clinical Research
- Pharmaceutical Analysis
- Quality Assurance
- Biopharmaceutical Sciences
Required Skills
- Strong experience in dossier preparation and regulatory submissions
- Knowledge of ICH guidelines and pharmacopoeial standards (USP, EP, IP)
- Exposure to biologics or sterile injectables (preferred)
- Excellent documentation and report writing skills
- Strong communication and cross-functional coordination abilities
Salary & Benefits
- Competitive salary based on experience and industry standards
- Opportunity to work on global regulatory projects
- Exposure to biologics and advanced pharmaceutical products
- Career growth in regulatory affairs and CMC documentation
How to Apply
Interested candidates can apply by sending their updated resume to:
Email: career@mjbiopharm.com
Application Instructions
- Use subject line: Application for Regulatory Affairs
- Mention the following details:
- Current CTC
- Expected CTC
- Notice Period