Executive Regulatory Affairs Job in Gujarat at Amb Pharma in Vadodara for M.Pharm professionals with experience in CDSCO compliance and regulatory submissions.
Company Overview
Amb Pharma is a growing pharmaceutical organization focused on regulatory compliance, quality-driven operations, and responsible product lifecycle management. The company works closely with Indian regulatory authorities to ensure that its pharmaceutical products meet current statutory and documentation standards. With an emphasis on accuracy, transparency, and continuous improvement, Amb Pharma provides a professional environment for regulatory affairs professionals seeking stability and long-term career growth in the Indian pharma industry. Executive Regulatory Affairs Job in Gujarat
Job Location & Employment Type
- Work Location: Vadodara, Gujarat, India
- Employment Type: Full-time, on-site role
Open Positions / Department Details
- Department: Regulatory Affairs
- Position Title: Executive – Regulatory Affairs
- Number of Openings: Not disclosed
This opportunity is suitable for experienced regulatory professionals who want to strengthen their expertise in Indian pharmaceutical regulations and dossier management.
Key Roles & Responsibilities
The Executive – Regulatory Affairs will play a critical role in managing regulatory documentation and ensuring compliance with applicable pharmaceutical laws and guidelines. The primary responsibilities include: Executive Regulatory Affairs Job in Gujarat
- Preparing, reviewing, and compiling regulatory dossiers in line with Indian regulatory requirements
- Managing submissions, renewals, and post-approval changes for pharmaceutical products
- Ensuring adherence to CDSCO and DCGI regulations throughout the product lifecycle
- Coordinating with internal departments such as QA, QC, Production, and R&D for regulatory documentation
- Responding to regulatory queries raised by authorities within defined timelines
- Maintaining accurate records of regulatory submissions, approvals, and correspondence
- Tracking regulatory updates, notifications, and guideline changes issued by Indian authorities
- Supporting internal and external audits related to regulatory affairs
- Assisting in compliance-related activities during inspections and reviews
- Ensuring proper archival and version control of regulatory documents
This role requires a strong understanding of regulatory procedures and the ability to work collaboratively across departments.
Eligibility Criteria
Education
- Master of Pharmacy (M.Pharm) is mandatory
- Specialization in Regulatory Affairs or related disciplines is preferred
Experience
- Minimum 2 years and maximum 5 years of relevant experience in pharmaceutical regulatory affairs
- Prior hands-on exposure to Indian regulatory submissions is essential
Skills Required
- Strong knowledge of Indian pharmaceutical regulatory frameworks
- Practical experience with CDSCO and DCGI documentation processes
- Excellent documentation, coordination, and organizational skills
- Ability to manage multiple regulatory tasks simultaneously
- Good written and verbal communication skills
- Familiarity with regulatory compliance tracking and submission timelines
Executive Regulatory Affairs Job in Gujarat
Salary & Benefits
- Estimated Salary Range: ₹4,00,000 to ₹7,00,000 per annum
- Stable employment in a growing pharmaceutical organization
- Exposure to end-to-end regulatory affairs operations
- Opportunities for professional learning and skill enhancement
- Structured and compliance-focused work environment
Selection Process
The selection process is expected to include:
- Shortlisting of applications based on eligibility and experience
- Interview and document verification
- Final selection based on technical knowledge and regulatory exposure
Only shortlisted candidates will be contacted by the employer. Executive Regulatory Affairs Job in Gujarat
How to Apply
Interested and eligible candidates should apply via email application only.
- Send your updated CV to: prakash@ambpharma.com
Candidates are advised to mention the position name clearly in the email subject line for better visibility.
Important Dates
- Last Date to Apply: Not specified (apply at the earliest)
Why Apply for This Pharma Job?
This role offers a valuable opportunity for regulatory professionals to work closely with Indian pharmaceutical compliance systems. Candidates will gain hands-on exposure to regulatory submissions, authority interactions, and compliance coordination. The position is ideal for professionals who want to build long-term expertise in regulatory affairs while contributing to a structured and quality-driven organization. With competitive compensation and a stable work environment, this role supports both professional development and career continuity. Executive Regulatory Affairs Job in Gujarat
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not associated with Amb Pharma or any recruiting organization. Job details are shared for informational purposes only. Candidates are advised to verify employer credentials before applying. Executive Regulatory Affairs Job in Gujarat
Final Call-to-Action
If you meet the eligibility criteria and are looking to advance your career in pharmaceutical regulatory affairs, apply now and take the next professional step. Executive Regulatory Affairs Job in Gujarat
