Join Softgel Healthcare as a Regulatory Affairs Officer

Softgel Healthcare Private Limited is hiring a Regulatory Affairs Officer to strengthen their regulatory team in Chennai. This full-time, on-site role is ideal for professionals with 2–5 years of experience in pharmaceutical regulatory affairs, particularly in global markets.

As a Regulatory Affairs Officer, you’ll play a key role in preparing, validating, and submitting regulatory dossiers across multiple regions including the US, EU/UK, Canada, Australia, Brazil, Saudi Arabia, and South Africa. If you are detail-oriented, organized, and passionate about regulatory compliance, this role offers significant career growth in the pharmaceutical industry.

Key Responsibilities

• Prepare and validate eCTD dossiers using tools like Educe or Lorenz Validator.
• Submit regulatory applications via the FDA ESG portal.
• Manage post-approval changes including Annual Reports and CBE-30 submissions.
• Review technical documents: analytical validations, specifications, stability data, and batch manufacturing records.
• Conduct risk assessments for elemental impurities, nitrosamines, and residual solvents.
• Handle ANDA labeling and FDA drug listings via CDER Direct Portal.
• Coordinate with CROs for BE studies and review protocols/reports.
• Ensure compliance across all regulatory guidelines.
• Use SAP/ERP systems for documentation and regulatory tracking.

Qualifications & Experience

• 2–4 years of experience in regulatory affairs within the pharmaceutical industry.
• Exposure to regulated markets such as US, EU, Canada, and Australia is preferred.
• Familiarity with eCTD submission, FDA ESG portal, ANDA submissions, and post-approval change management.
• Strong analytical and documentation skills.
• Knowledge of SAP or ERP systems is a plus.

Benefits

• Competitive salary in line with industry standards (₹5–8 LPA).
• Opportunity to work with global regulatory submissions.
• Professional growth in a leading pharmaceutical company.
• Exposure to multiple regulatory markets.

How to Apply

Interested candidates can send their resume to:

• Primary: pna@softgelhealthcare.com
• CC: career@softgelhealthcare.com