Harman Finochem Wanted Senior Regulatory Affairs Specialist | Apply Now
- About Harman Finochem
- Job Title: Senior Regulatory Affairs Specialist
- Location:
- Job Responsibilities
- Required Qualifications & Experience
- How to Apply?
- Job Summary Table
Harman Finochem Recruitment Notification
About Harman Finochem
Harman Finochem Ltd. is a leading pharmaceutical company specializing in high-quality Active Pharmaceutical Ingredients (APIs) and finished formulations. With a strong global presence, the company is committed to regulatory excellence, ensuring compliance with international health authorities such as the US-FDA, EMA, and Health Canada.
If you have expertise in regulatory affairs and want to advance your career in a dynamic pharmaceutical environment, this opportunity is perfect for you!
Job Title: Senior Regulatory Affairs Specialist
Location:
Shendra, Aurangabad, Maharashtra, India
Job Responsibilities
- Review, compile, and submit regulatory application dossiers to agencies like US-FDA, EMA, and Health Canada.
- Collaborate with R&D, Business Development, and Manufacturing teams to streamline regulatory processes.
- Provide guidance to R&D scientists on formulation development and compliance with regulatory guidelines.
- Review and approve regulatory Chemistry, Manufacturing, and Controls (CMC) documents, including stability reports, method validation, and process validation.
- Conduct extensive literature research to understand market-specific regulatory requirements.
- Maintain comprehensive documentation and history for each drug product.
- Coordinate and provide regulatory support during audits and inspections.
Required Qualifications & Experience
- Education: M. Pharmacy (Pharmaceutical Chemistry)
- Experience: 6-9 years in the Formulation (Oral Solid Dosage) industry, with Regulatory Affairs (RA) exposure in US and Europe markets.
- Technical Skills:
- Expertise in regulatory submissions for major international markets.
- Strong knowledge of guidelines such as FOIA, EMEA, and Health Canada regulations.
- Experience in compiling and reviewing CMC documentation.
- Ability to coordinate with cross-functional teams.
- Proficiency in Microsoft Office applications and regulatory software.
How to Apply?
Interested candidates can apply through the official Harman Finochem job portal or LinkedIn: 👉 Apply Now
Job Summary Table
| Company Name | Current Vacancies | Required Education | Experience Required |
|---|---|---|---|
| Harman Finochem Ltd | Senior Regulatory Affairs Specialist | M. Pharm (Pharmaceutical Chemistry) | 6-9 years (Formulation, RA – US & Europe) |
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