Executive

Enzene; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Enzene in Pune seeks an experienced Regulatory Affairs professional specializing in biosimilars. Responsibilities include reviewing CMC, drafting eCTD modules, and coordinating with cross-functional teams to ensure timely regulatory submissions for US and ROW markets.

The role focuses on ICH guidelines, including ACTD/CTD, and requires 2-5 years in biosimilars or pharma regulatory affairs; a Master's degree in Pharmacy or Life Sciences is preferred.

Qualifications

• 2-5 years of experience in biosimilar/pharmaceutical regulatory affairs.
• Strong understanding of ACTD, Biosimilars, CTA, CTD, and dossier submission processes.
• Experience with US and/or European markets (ROW) is desirable.

Responsibilities

• Review of CMC documents for US FDA and EMA submissions.
• Draft eCTD sections and modules per regulatory requirements.
• Prepare regulatory submissions including IND, IMPD and briefing books.
• Coordinate with cross-functional teams to ensure timely document delivery.
• Ensure regulatory communications are clear, accurate and compliant.
• Apply biosimilar guidelines and ICH standards throughout submissions.
• Manage PDF properties and formatting for eCTD submissions.
• Stay updated on global regulatory requirements, including CDSCO and ICH.
• Provide strategic guidance on regulatory strategy for biosimilars.
• Assist in submissions including RCGM, Clinical trial applications, and post-approval changes.

Skills

Regulatory affairs

Biosimilars

CTD/IND submissions

eCTD documentation

Cross-functional collaboration

Education

Master's degree in Pharmacy/Life Sciences

Job description

Roles and Responsibilities :

• Review of CMC Documents: Evaluate Chemistry, Manufacturing, and Controls (CMC) documentation for US FDA and EMA submissions.
• Drafting eCTD Sections: Prepare and compile electronic Common Technical Document (eCTD) modules in compliance with regulatory requirements.
• Regulatory Document Preparation: Draft regulatory submissions including IND (Investigational New Drug), IMPD (Investigational Medicinal Product Dossier), and briefing books (BB).
• Cross-Functional Communication: Collaborate effectively with internal CFTs to ensure alignment and timely delivery of regulatory documents.
• Regulatory Language Expertise: Ensure clarity, accuracy, and compliance in all regulatory communications and documentation
• Biosimilar Expertise: Apply knowledge of biosimilar guidelines and requirements, including ICH standards, throughout the submission process.
• Technical Proficiency: Manage PDF properties and formatting requirements for eCTD submissions.
• Compliance: Stay updated on global regulatory requirements, including ICH guidelines for biosimilars.
• Provide strategic guidance on regulatory strategy development for biosimilars products.
• Assist in the preparation and submission of regulatory filings, including RCGM submission, Clinical trial application, new marketing applications, Post approval changes, renewals, and responses to regulatory queries.
  
• Stay informed about regulatory requirements and guidelines for biopharmaceutical products in domestic and ROW markets, including CDSCO, ICH, local FDA and other global regulatory agencies.
  

Job Requirements :

• 2-5 years of experience in Biosimilar/ pharmaceutical industry with expertise in drug regulatory affairs.
• Strong understanding of ActD, ACTD, Biosimilars, CTA, CTD, Dossier preparation & submission processes.
• Experience working in US Market or European Markets (ROW) is desirable.
• Master’s degree in Pharmacy, Life Sciences, or related field