Regulatory Affairs Officer – Regulatory Affairs | Medispark Healthcare | Ahmedabad, Gujarat, India
Medispark Healthcare is hiring a Regulatory Affairs Officer in Ahmedabad, Gujarat, India. This opportunity is ideal for fresh B.Pharm graduates or candidates with up to 1 year of experience looking to build a career in the pharmaceutical regulatory domain. The role focuses on supporting regulatory documentation, compliance processes, and submission activities required for pharmaceutical product approvals. Working with the regulatory team, the candidate will assist in preparing dossiers, maintaining regulatory records, and ensuring compliance with national and international regulatory standards. The position provides exposure to pharmaceutical regulations, product registrations, and regulatory strategy development. Medispark Healthcare operates within the pharmaceutical industry and focuses on delivering quality healthcare products while maintaining strict regulatory compliance.
Location
Ahmedabad, Gujarat, India
Employment Type
Full-time
Experience Required
0–1 Years
Compensation & Benefits
Salary: Not Disclosed
Additional benefits as per company policy.
About Medispark Healthcare
Medispark Healthcare is a pharmaceutical organization engaged in developing and delivering healthcare products that meet strict regulatory and quality standards. The company focuses on compliance, innovation, and maintaining global pharmaceutical quality benchmarks.
Position Overview
The Regulatory Affairs Officer supports regulatory documentation, submission preparation, and compliance activities required for pharmaceutical product approvals and lifecycle management.
Key Responsibilities
- Prepare and review regulatory documentation and product dossiers.
- Assist in compiling regulatory submissions for product registrations.
- Maintain updated regulatory records and documentation.
- Ensure compliance with pharmaceutical regulatory guidelines.
- Coordinate with internal departments for regulatory data collection.
- Track regulatory submissions and approval timelines.
- Assist in responding to regulatory authority queries.
- Support regulatory audits and documentation reviews.
- Ensure regulatory updates are communicated to internal teams.
- Maintain regulatory compliance across pharmaceutical products.
Required Skills & Competencies
- Knowledge of pharmaceutical regulatory requirements.
- Understanding of dossier preparation and submission processes.
- Strong documentation and record management skills.
- Attention to detail and compliance orientation.
- Basic understanding of pharmaceutical guidelines.
- Ability to coordinate with cross-functional teams.
- Strong written and verbal communication skills.
- Time management and organizational abilities.
- Ability to handle regulatory documentation efficiently.
- Interest in pharmaceutical regulatory affairs.
Educational Qualification
B.Pharm
About the Project & Industry
The pharmaceutical regulatory sector ensures medicines meet regulatory standards for safety, quality, and efficacy before entering the market. Regulatory professionals play a critical role in maintaining compliance and facilitating approvals from health authorities.
Why Join Medispark Healthcare?
Medispark Healthcare provides opportunities for young professionals to develop expertise in regulatory affairs while working within a professional pharmaceutical environment that emphasizes compliance and product quality.
How to Apply
Interested candidates can apply by sending their updated resume to: careers@medisparkhealthcare.com
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