M.J. Biopharm Hiring Regulatory Affairs Executive

M.J. Biopharm Hiring Regulatory Affairs Executive | Biologics Pharma Jobs Pune

M.J. Biopharm Pvt. Ltd. is actively hiring for the position of Executive – Regulatory Affairs (RA) at its Pune location. This opportunity is ideal for professionals with 3 to 5 years of experience in CMC regulatory affairs, especially those with exposure to biologics and sterile injectables. Candidates with a background in M.Pharm, B.Pharm, Biotechnology, or Life Sciences can apply.

This hiring drive focuses on experienced professionals who want to build a strong career in regulatory submissions, dossier preparation, and global pharmaceutical compliance. The role offers hands-on exposure to CTD/eCTD documentation, ICH guidelines, and cross-functional coordination with R&D, QA, and QC teams.

Company Overview

M.J. Biopharm Pvt. Ltd. is a growing pharmaceutical and biotechnology company specializing in biologics, sterile injectables, and advanced drug development solutions. The company is known for its commitment to quality, innovation, and regulatory excellence in the global healthcare market.

With increasing demand for biologics and complex pharmaceutical products, M.J. Biopharm provides professionals the opportunity to work on high-value regulatory projects, ensuring compliance with international standards such as USFDA and ICH guidelines.

Job Role & Responsibilities

Executive – Regulatory Affairs (CMC)

• Prepare and review CMC dossiers in CTD/eCTD format (Module 3)
• Support global regulatory submissions and handle deficiency responses
• Collaborate with Analytical, QC, QA, and R&D teams for data compilation
• Ensure compliance with ICH guidelines and international regulatory standards
• Review analytical data and characterization reports for biologics
• Maintain accurate documentation and ensure data integrity
• Contribute to regulatory strategy and submission timelines

Eligibility / Qualifications

Required Education

M.Pharm, B.Pharm, Biotechnology, Life Sciences

Relevant Courses

Regulatory Affairs, Pharmaceutical Biotechnology, Drug Regulatory Affairs, Clinical Research, Pharmaceutical Analysis, Quality Assurance, Biopharmaceutical Sciences

Experience

• 3 to 5 years in Regulatory Affairs (CMC)

Skills Required

• Strong experience in dossier preparation and regulatory submissions
• Knowledge of ICH guidelines and pharmacopoeial standards (USP, EP, IP)
• Exposure to biologics or sterile injectable products (preferred)
• Excellent report writing and documentation skills
• Strong coordination and communication abilities

Location & Salary

Job Location

• Pune, Maharashtra

Salary

• Competitive salary based on experience and industry standards

Application Process

Interested candidates can apply by sending their updated resume to:

• career@mjbiopharm.com

Application Instructions

• Mention subject line: Application for Regulatory Affairs
• Include details: Current CTC, Expected CTC, Notice Period

Why You Should Apply

• Opportunity to work in biologics and sterile injectable domain
• Exposure to global regulatory submissions and compliance systems
• Work with experienced cross-functional pharma teams
• Strong career growth in regulatory affairs and CMC documentation

FAQs

What qualification is required?

Candidates should have M.Pharm, B.Pharm, Biotechnology, or Life Sciences background.

How much experience is needed?

3 to 5 years of experience in Regulatory Affairs (CMC).

Is biologics experience mandatory?

It is preferred but not mandatory.

What is the job location?

Pune, Maharashtra.

What skills are important for this role?

Dossier preparation, ICH guidelines knowledge, and regulatory documentation skills are essential.

Summary Table

Company	M.J. Biopharm Pvt. Ltd.
Vacancies	Executive – Regulatory Affairs (CMC)
Required Education	M.Pharm, B.Pharm, Biotechnology, Life Sciences
Experience	3–5 Years