Micro Orgo Chem, a rapidly expanding Active Pharmaceutical Ingredient (API) manufacturer, is currently hiring a Regulatory Affairs Executive to support regulatory documentation, dossier preparation, and compliance activities.
This opportunity is ideal for candidates with a B.Pharm, M.Pharm, Chemistry, or Life Sciences background who are interested in regulatory affairs, pharmaceutical documentation, and global compliance in the API manufacturing sector.
Working with Micro Orgo Chem offers exposure to GMP-regulated manufacturing environments, regulatory submissions, and pharmaceutical quality standards, making it an excellent opportunity for professionals looking to grow in pharmaceutical regulatory affairs careers in India.
About Micro Orgo Chem
Micro Orgo Chem is a trusted API manufacturer serving both Indian and international pharmaceutical companies. The organization focuses on:
- High-quality Active Pharmaceutical Ingredient manufacturing
- Strict adherence to GMP and global regulatory standards
- Efficient production and supply chain management
- Delivering consistent pharmaceutical quality and reliability
The company operates a fully integrated pharmaceutical production facility and employs experienced QA and regulatory professionals to ensure compliance with global pharmaceutical regulations.
Regulatory Affairs Executive โ Key Responsibilities
The Regulatory Affairs Executive role involves supporting pharmaceutical regulatory compliance and ensuring product documentation meets global regulatory standards.
Key responsibilities include:
- Preparing regulatory documentation for pharmaceutical products
- Managing dossier preparation and regulatory submissions
- Ensuring compliance with national and international regulatory requirements
- Collaborating with quality assurance, manufacturing, and regulatory teams
- Monitoring updates in pharmaceutical regulatory guidelines
- Maintaining regulatory records and documentation
- Supporting regulatory strategies for product approvals
- Ensuring compliance with GMP regulations and regulatory frameworks
Professionals in this role play a critical role in ensuring pharmaceutical products meet global compliance standards and regulatory approvals.
Eligibility Criteria
Candidates applying for the Regulatory Affairs Executive position should meet the following qualifications.
Education
- B.Pharm
- M.Pharm
- BSc / MSc in Chemistry
- Any related Life Sciences degree
Skills & Knowledge
- Knowledge of pharmaceutical regulatory affairs processes
- Experience in regulatory documentation
- Understanding of dossier preparation
- Familiarity with pharmaceutical regulatory guidelines
- Strong attention to detail and documentation skills
- Good communication and organizational abilities
Candidates with exposure to API regulatory affairs, regulatory submissions, or compliance management will have an advantage.
Why Consider a Career in Regulatory Affairs?
Regulatory affairs professionals are responsible for ensuring pharmaceutical products meet government regulations and international standards.
Career advantages include:
- High demand in pharmaceutical and biotech industries
- Opportunities in global drug approvals
- Exposure to international regulatory agencies
- Growth into roles such as
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Global Regulatory Lead
Regulatory affairs is one of the most stable and strategic career paths in the pharmaceutical industry.
Salary Range
Estimated salary for a Regulatory Affairs Executive in API companies in India:
โน3.5 LPA โ โน6 LPA
Salary may vary based on experience, regulatory knowledge, and pharmaceutical industry exposure.
Job Details
| Field | Details |
|---|---|
| Job Role | Regulatory Affairs Executive |
| Company | Micro Orgo Chem |
| Industry | Pharmaceutical / API Manufacturing |
| Job Type | Full Time |
| Work Mode | On-site |
| Location | Vapi, Gujarat, India |
| Qualification | B.Pharm / M.Pharm / Chemistry / Life Sciences |
| Experience | Entry level / relevant regulatory exposure preferred |
How to Apply
