Enzene Biosciences Ltd. is hiring for an Executive – Global Regulatory Affairs position in Pune, Maharashtra. The opportunity is aimed at professionals with 2–5 years of experience in the pharmaceutical or biosimilar industry, particularly those with expertise in regulatory affairs, CMC documentation and global regulatory submissions.

The role involves preparing and reviewing regulatory documentation for major markets, including the US FDA and European EMA, while supporting regulatory strategy and submissions for biosimilar products. The currently listed role closely matches the responsibilities provided in this vacancy.

Job Highlights

Roles and Responsibilities

Selected candidates will be responsible for regulatory documentation, global submissions and coordination with cross-functional teams.

• Review CMC documents for US FDA and EMA regulatory submissions.
• Prepare and compile eCTD sections according to applicable regulatory and technical requirements.
• Draft regulatory documents including IND, IMPD and Briefing Books.
• Coordinate with cross-functional teams to ensure timely preparation of submission documents.
• Ensure appropriate regulatory language, accuracy and consistency across documentation.
• Handle PDF properties, formatting and technical requirements for eCTD submissions.
• Apply knowledge of biosimilar guidelines and ICH requirements.
• Support regulatory strategy development for biosimilar products.
• Assist with RCGM submissions, clinical trial applications, marketing applications, post-approval changes and renewals.
• Prepare responses to regulatory queries and support interactions with health authorities.
• Track regulatory requirements for biopharmaceutical products across India, US, Europe and other ROW markets.
• Maintain knowledge of applicable CDSCO, ICH, FDA and other global regulatory guidelines.

The current public listing also confirms the focus on CMC documents, eCTD preparation, IND/IMPD/Briefing Book documentation, cross-functional collaboration and biosimilar regulatory requirements.

Required Qualifications

Candidates should have:

• A Master’s degree in Pharmacy, Life Sciences or a related discipline.
• Relevant exposure to Regulatory Affairs within the pharmaceutical or biosimilar industry.
• 2–5 years of professional experience in regulatory affairs.
• Strong understanding of ACTD, CTD, biosimilars, CTA and dossier preparation/submission processes.
• Knowledge of global regulatory requirements and ICH guidelines.
• Experience with US or European regulatory markets is desirable.
• Understanding of regulatory submissions and lifecycle activities for biopharmaceutical products.

Preferred Educational Background

The supplied job information specifically lists postgraduate qualifications including:

• M.Pharm
• M.Sc. in Biotechnology, Organic Chemistry, Biochemistry, Biology or Microbiology
• M.Tech in Biochemistry/Biotechnology/Biomedical-related disciplines

Key Skills

Important skills associated with this opportunity include:

• Regulatory Affairs
• Drug Regulatory Affairs
• Biosimilars
• CMC Documentation
• Dossier Preparation
• eCTD
• ACTD
• CTD
• CTA
• US Market Regulatory Submissions
• ROW Markets
• RCGM
• ICH Guidelines
• Regulatory Strategy
• Submission Management

Salary and Benefits

Enzene has not publicly disclosed the salary for this particular vacancy in the information reviewed. For JobPosting purposes, the salary range below is presented as a realistic market estimate, not an officially announced Enzene salary:

Estimated Salary: ₹6–12 LPA, depending on relevant experience, regulatory expertise and overall profile.

Potential benefits for a full-time permanent role may include company-standard employee benefits, professional development and exposure to global regulatory projects; candidates should confirm the exact benefits directly with Enzene during the recruitment process.

Why Consider This Enzene Opportunity?

This position can provide professionals with exposure to global regulatory submissions, biosimilars, CMC documentation and major regulatory markets such as the US and Europe. The role also offers interaction with cross-functional teams across quality, manufacturing, analytical and clinical functions.

Enzene describes itself as a continuously innovative development and manufacturing partner for innovators and biosimilar developers, with operations spanning Pune, India, and Hopewell, New Jersey.

How to Apply for Enzene Jobs

Application Link