Enzene Biosciences
Website:
enzene.com
Job details:
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.
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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."
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