Deputy Manager – Regulatory Affairs (NCE | CDSCO & Global Regulatory Agencies)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Function: Regulatory Affairs – New Chemical Entities (NCE)
Job ID: 7190
Application Deadline: 15 February 2026
Job Overview
We are seeking an experienced Deputy Manager – Regulatory Affairs to support New Chemical Entity (NCE) development programs and regulatory submissions across India and global markets. This role plays a critical part in executing regulatory strategies, preparing high-quality dossiers, and coordinating with CDSCO and international health authorities to support clinical development and product approvals.
The position is well-suited for regulatory professionals with strong exposure to eCTD submissions, global regulatory guidelines, and cross-functional collaboration in a pharmaceutical development environment.
Key Responsibilities
Regulatory Strategy & Submissions
Support the development and execution of regulatory strategies for NCE programs, including 505(b)(2) pathways.
Prepare, compile, review, and publish IND, NDA, ANDA, and MAA dossiers in eCTD format.
Coordinate timely and compliant regulatory submissions to CDSCO and global regulatory agencies.
Ensure all submissions align with ICH, US FDA, EMA, CDSCO, and other applicable global guidelines.
Regulatory Communication & Compliance
Assist in preparing responses to regulatory queries, deficiency letters, and follow-up requests.
Coordinate communications with regulatory authorities, partner affiliates, and internal stakeholders under supervision.
Support planning, documentation, and follow-up of regulatory meetings with health authorities.
Track changes in regulatory requirements and disseminate regulatory intelligence to cross-functional teams.
Cross-Functional Collaboration
Work closely with R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to provide regulatory guidance throughout the product lifecycle.
Support regulatory documentation and submissions for clinical trial applications and development milestones.
Assist in audit readiness and provide support during regulatory inspections.
Documentation & Process Excellence
Maintain regulatory archives, submission trackers, and documentation repositories for assigned projects.
Conduct regulatory intelligence activities, including monitoring global guideline updates and competitor regulatory activity.
Support senior regulatory professionals and contribute to process standardization and continuous improvement initiatives within the regulatory function.
Education & Qualifications
Master’s Degree (M. Pharm) is mandatory.
Experience Requirements
5 to 8 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience supporting NCE development programs and interacting with CDSCO and global regulatory agencies.
Hands-on exposure to eCTD dossier preparation, publishing, and lifecycle management is essential.
Key Skills & Competencies
Strong knowledge of global regulatory guidelines (ICH, US FDA, EMA, CDSCO).
Experience with IND, NDA, ANDA, MAA, and clinical trial submissions.
Familiarity with 505(b)(2) regulatory pathways.
Understanding of GxP requirements and pharmacovigilance interfaces.
Excellent documentation, organizational, and stakeholder coordination skills.
Ability to work effectively in cross-functional and matrix environments.
About the Organization
Amneal is an equal opportunity employer committed to building a diverse and inclusive workplace. We value integrity, collaboration, and professional growth, and we strive to create an environment where employees can contribute meaningfully to global healthcare outcomes.
Why Join This Role?
This position offers exposure to global regulatory development, innovative NCE programs, and direct interaction with leading health authorities. It provides an excellent platform for regulatory professionals looking to deepen expertise in international submissions and strategic regulatory planning.
Apply Now
Qualified candidates are encouraged to apply through thepharmadaily.com to be considered for this high-impact Regulatory Affairs leadership opportunity.
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