Executive-CMCRA

Enzene Biosciences Ltd; Maharashtra; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Enzene Biosciences Ltd is seeking an Executive- CMCRA to assist in regulatory filings and ensure timely submissions across domestic and ROW markets. You will collaborate with R&D, QA, Manufacturing, and other teams to integrate regulatory requirements into development plans and commercial strategies.

The role demands a Master’s degree in Pharmacy or Life Sciences and 1–7 years of progressive regulatory affairs experience, with strong knowledge of CDSCO, ICH, and global guidelines.

Qualifications

• Master's degree in Pharmacy, Life Sciences, or related field.
• 1–7 years of progressive regulatory affairs experience in pharma/biotech.
• Experience with domestic and ROW markets.
• Experience in regulatory submissions and interactions is essential.

Responsibilities

• Assist in preparation and submission of regulatory filings (RCGM, CTA, new marketing authorisations).
• Ensure completeness and timeliness of submissions to regulators in domestic and ROW markets.
• Stay updated on regulatory requirements (CDSCO, ICH, Local FDA, other global agencies).
• Support compliance across product lifecycle with cross-functional teams.
• Maintain regulatory documentation and databases per standards.
• Collaborate with R&D, QA, Manufacturing and other departments to integrate regulatory needs.
• Provide updates to teams to ensure proactive compliance and strategic decisions.
• Monitor regulatory developments and industry trends impacting products.

Skills

Regulatory submissions

Regulatory affairs

CDSCO/ICH guidelines

Domestic & ROW markets

Cross-functional collaboration

Documentation & records

Regulatory audits & CAPA

Regulatory knowledge

Education

Master's degree in Pharmacy or Life Sciences

Tools

Regulatory databases

Job description

Executive- CMCRA

\"Role & Responsibilities -

• 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.
• Ensure completeness, accuracy, and timeliness of submissions to regulatory authorities in domestic and ROW markets.
• 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.
• Support compliance efforts across all stages of the product lifecycle, collaborating closely with regulatory and cross-functional teams.
• Maintain regulatory documentation, records, and databases in accordance with regulatory standards and company policies.
• Ensure accurate and up-to-date documentation for regulatory submissions, approvals, and correspondence.
• Collaborate with R&D, Clinical Development, Quality Assurance, Manufacturing, and other departments to integrate regulatory requirements into product development plans and commercial strategies.
• Facilitate communication and alignment on regulatory matters to support project timelines and business objectives.
• Monitor regulatory developments, trends, and changes affecting biopharmaceutical products in domestic and ROW markets.
• Provide updates and recommendations to regulatory and cross-functional teams to ensure proactive compliance and strategic decision-making.
• Assist in regulatory aspects of quality assurance activities, including audits, CAPA management, and compliance assessments.
• Collaborate with QA teams to ensure adherence to regulatory standards and continuous improvement initiatives.
• Solid understanding of regulatory requirements and guidelines for biopharmaceutical products in domestic and ROW markets, including RCGM, CDSCO, ICH, Local FDA and other global agencies. Experience with regulatory submissions and interactions is essential
• Product knowledge and understanding of the regulatory guidelines.
• Strong organizational skills with attention to detail. Effective communication and interpersonal skills to collaborate with diverse teams and stakeholders. Ability to manage multiple priorities and work effectively in a fast-paced environment.

Qualification :

Master's degree in a Pharmacy, Life Sciences, or a related field (e.g., Biology, Biotechnology, Biochemistry)

Experience :

Minimum of 1-7 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industries, with experience in domestic and ROW markets. Previous experience in a regulatory affairs role focusing on biopharmaceuticals is preferred.\"