Executive Regulatory Affairs API Jobs at Cadila Pharmaceuticals in Dholka for M.Sc and M.Pharm candidates with experience.
Company Overview
Cadila Pharmaceuticals Limited is a well-known Indian pharmaceutical organization with a strong presence across formulations, active pharmaceutical ingredients (APIs), and research-driven healthcare solutions. The company is recognized for its compliance-focused manufacturing practices, strong R&D capabilities, and commitment to global regulatory standards. Cadila offers professionals a structured work environment, exposure to international regulatory markets, and long-term career growth opportunities in the pharmaceutical regulatory domain. Executive Regulatory Affairs API Jobs
Job Location & Employment Type
- Job Location: Dholka, Gujarat
- Employment Type: Full-time
- Industry: Pharmaceutical / API Manufacturing
- Functional Area: Regulatory Affairs
Open Positions / Department Details
Cadila Pharmaceuticals is currently hiring for the role of Executive – Regulatory Affairs (API) within its R&D Regulatory Affairs department. This position is focused on regulatory documentation, dossier preparation, and compliance support for API products intended for domestic and international markets. The role is ideal for professionals with foundational experience in API regulatory affairs who wish to strengthen their expertise in global submissions and regulatory lifecycle management. Executive Regulatory Affairs API Jobs
Key Roles & Responsibilities
API Regulatory Dossier Preparation
- Prepare, compile, and maintain regulatory dossiers for Active Pharmaceutical Ingredients in line with CTD and eCTD formats.
- Support the creation of high-quality documentation for Drug Master Files (DMFs) and other regulatory submissions.
- Ensure accuracy, consistency, and completeness of regulatory data before submission.
Regulatory Submissions & Lifecycle Management
- Assist in initial submissions, variations, renewals, and post-approval changes for API products.
- Respond to regulatory authority queries, deficiency letters, and information requests within defined timelines.
- Maintain updated records of submission status, approvals, and commitments.
Executive Regulatory Affairs API Jobs
Cross-Functional Coordination
- Work closely with R&D, Quality Assurance, Quality Control, and Production teams to gather required technical and compliance data.
- Coordinate internally to resolve documentation gaps and ensure alignment with regulatory expectations.
- Facilitate smooth information flow between departments involved in regulatory activities.
Compliance & Regulatory Intelligence
- Ensure regulatory documents are aligned with current international guidelines and agency requirements.
- Support ongoing compliance activities related to API manufacturing and documentation.
- Assist in tracking regulatory updates and implementing changes in documentation practices when required.
Documentation Control & Record Maintenance
- Maintain structured regulatory archives and electronic documentation systems.
- Ensure version control, traceability, and proper indexing of regulatory documents.
- Support internal audits and regulatory inspections by providing timely documentation.
Executive Regulatory Affairs API Jobs
Eligibility Criteria
Education
- Master of Science (M.Sc) in a relevant discipline
OR - Master of Pharmacy (M.Pharm) with exposure to API regulatory affairs
Experience
- Minimum 1 year of hands-on experience in Regulatory Affairs related to APIs
- Experience in DMF preparation or regulatory documentation will be preferred
Skills Required
- Working knowledge of API regulatory documentation and submission processes
- Understanding of international regulatory guidelines such as ICH, USFDA, EMA, and related agencies
- Strong documentation and analytical skills
- Ability to coordinate effectively with cross-functional teams
- Good written and verbal communication skills
- Familiarity with regulatory databases and document management systems
Salary & Benefits
- Salary: As per company norms
- Performance-based growth opportunities
- Exposure to global regulatory submissions
- Professional learning environment within an established pharmaceutical organization
- Long-term career development in API regulatory affairs
Executive Regulatory Affairs API Jobs
Selection Process
- Initial application screening
- Shortlisting based on qualification and experience
- Technical interview and HR discussion
- Final selection as per company recruitment guidelines
How to Apply
Interested candidates are required to apply through the official email or application link provided by the company.
IndiaPharmaJobs.in does not collect resumes or conduct hiring on behalf of any organization. Executive Regulatory Affairs API Jobs
Important Dates
- Job Posted On: February 4, 2026
- Last Date to Apply: Not mentioned (early application recommended)
Why Apply for This Pharma Job?
This opportunity offers hands-on exposure to API regulatory affairs within a reputed pharmaceutical organization. The role allows candidates to strengthen their skills in DMF preparation, global regulatory compliance, and dossier lifecycle management. Working at Cadila Pharmaceuticals provides a stable professional environment, learning opportunities from experienced regulatory professionals, and the chance to build a long-term career in the regulatory domain. For candidates aiming to grow in API regulatory affairs, this role offers both technical depth and career progression. Executive Regulatory Affairs API Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not affiliated with Cadila Pharmaceuticals Limited or any other company. Job details are shared for informational purposes only. Candidates are advised to verify information and apply through official company communication channels. Executive Regulatory Affairs API Jobs
Final Call-to-Action
If you have experience in API regulatory affairs and are looking to advance your career with a reputed pharmaceutical organization, apply now and take the next step toward professional growth in regulatory sciences. Executive Regulatory Affairs API Jobs
