Softgel Healthcare Hiring Regulatory Affairs Officer
Position: Regulatory Affairs Officer
Company: Softgel Healthcare Pvt. Ltd.
Qualification: B.Pharm, M.Pharm, M.Sc
Location: Chennai, India
Experience: 2–4 Years
Employment Type: Full-Time (On-site)
Verified Job
Application Mode: Email
Job Overview
Softgel Healthcare Private Limited, a fast-growing pharmaceutical company known for its global-quality formulations and export operations, is inviting applications for the position of Regulatory Affairs Officer at its Chennai facility. Softgel Healthcare Hiring Regulatory Affairs Officer
This role is ideal for professionals with 2–4 years of experience in pharmaceutical regulatory affairs, particularly those familiar with US, EU, Canada, and other regulated markets. The selected candidate will play a vital role in compiling, validating, and submitting global regulatory dossiers to ensure compliance with international standards.
If you’re passionate about pharmaceutical compliance and eager to work on diverse global submissions, this opportunity at Softgel Healthcare offers both learning and leadership potential. Softgel Healthcare Hiring Regulatory Affairs Officer
Key Responsibilities
As a Regulatory Affairs Officer, your responsibilities will include: Softgel Healthcare Hiring Regulatory Affairs Officer
- Preparing and validating eCTD dossiers using platforms such as Educe or Lorenz Validator.
- Submitting regulatory filings through the FDA ESG portal and maintaining proper documentation.
- Managing post-approval changes, including Annual Reports and CBE-30 submissions.
- Reviewing analytical validation data, stability studies, specifications, and batch manufacturing records.
- Conducting risk assessments related to elemental impurities, nitrosamines, and residual solvents.
- Preparing and maintaining ANDA labeling and handling FDA drug listings through the CDER Direct Portal.
- Coordinating with CROs (Contract Research Organizations) for bioequivalence (BE) studies, including protocol and report review.
- Ensuring compliance with international regulatory guidelines (USFDA, EMA, MHRA, TGA, etc.).
- Maintaining documentation and tracking through SAP or ERP systems.
Required Qualifications & Experience
- Educational Qualification: B.Pharm, M.Pharm, or M.Sc (Life Sciences or Chemistry).
- Experience: 2–4 years in Regulatory Affairs within the pharmaceutical industry.
- Hands-on experience in ANDA submissions, eCTD compilation, and FDA ESG portal usage.
- Knowledge of post-approval lifecycle management and labeling requirements.
- Familiarity with global market submissions (US, EU/UK, Canada, Australia, Brazil, Saudi Arabia, South Africa).
- Proficiency in MS Office, SAP/ERP tools, and regulatory document management.
- Excellent attention to detail and strong analytical skills.
- Softgel Healthcare Hiring Regulatory Affairs Officer
Salary and Benefits
- Salary Range: ₹5 – ₹8 LPA (commensurate with experience).
- Opportunity to work on global regulatory projects and multi-country submissions.
- Exposure to international pharmaceutical compliance systems.
- Long-term career growth within a reputed organization.
- Supportive and knowledge-driven work culture.
About the Company
Softgel Healthcare Pvt. Ltd. is a trusted name in pharmaceutical manufacturing and export, specializing in softgel and other oral dosage forms. The company adheres to international quality and regulatory standards, serving clients across the US, EU, LATAM, MENA, and Asia-Pacific regions. Softgel Healthcare Hiring Regulatory Affairs Officer
With a focus on regulatory excellence and compliance-driven operations, Softgel Healthcare continues to expand its presence in regulated and semi-regulated markets worldwide. Softgel Healthcare Hiring Regulatory Affairs Officer
How to Apply
Interested candidates can apply by sending their updated resume to the following email addresses:
📧 Primary: pna@softgelhealthcare.com
📧 CC: career@softgelhealthcare.com
Subject Line: Application for Regulatory Affairs Officer – [Your Name]
Location: Chennai
Deadline: Apply before October 31, 2025 for priority consideration.
Summary
This is an excellent opportunity for regulatory professionals seeking growth in an export-oriented pharmaceutical company. With hands-on exposure to international filings and post-approval processes, Softgel Healthcare provides a platform to enhance your expertise in global regulatory affairs. Softgel Healthcare Hiring Regulatory Affairs Officer
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