Executive-CMCRA

Enzene Biosciences Ltd; Maharashtra; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking an Executive CMCRA to support regulatory filings and submissions across domestic and ROW markets. The role requires collaboration with R&D, QA, regulatory teams, and external authorities to ensure compliant timelines.

Candidates should have a Master’s degree in Pharmacy or Life Sciences and 1–7 years of regulatory affairs experience, with strong organizational and communication skills for fast-paced environments.

Qualifications

• Master’s degree in Pharmacy, Life Sciences, or related field.
• 1–7 years in regulatory affairs in pharma/biotech; domestic and ROW markets.
• Experience with regulatory submissions and interactions is essential.
• Strong organizational and communication skills; ability to manage multiple priorities.

Responsibilities

• Assist in preparation and submission of regulatory filings (RCGM, CTR, new marketing applications, post-approval changes, renewals).
• Ensure completeness, accuracy, and timeliness of submissions to regulatory authorities in domestic and ROW.
• Maintain regulatory documentation and databases.
• Collaborate with R&D, Clinical Development, QA, Manufacturing to integrate regulatory requirements.
• Monitor regulatory developments and provide updates to teams for proactive compliance.
• Assist in QA activities including audits and CAPA management.

Skills

Regulatory filings

Regulatory submissions

Documentation control

Cross-functional collaboration

Regulatory monitoring

Education

Master’s degree in Pharmacy/Life Sciences

Job description

• 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)

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.

Ø

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.