Regulatory Affairs (RA) Officer

Why This Role Matters
The Regulatory Affairs (RA) Officer ensures that pharmaceutical manufacturing operations remain compliant with regulatory and quality standards. Through accurate validation documentation, QMS record maintenance, and SOP preparation, this role directly supports audit readiness, product quality, and regulatory compliance. Strong documentation practices help prevent compliance gaps and maintain smooth regulatory operations.

Job Description
Wings Biotech LLP is seeking a Regulatory Affairs Officer for its Baddi location. The role focuses on validation documentation, QMS maintenance, APQR preparation, and SOP drafting. The selected candidate will support regulatory and quality systems through structured documentation and compliance activities.

Key Features of the Role
• Position: Regulatory Affairs (RA) Officer
• Location: Baddi
• Experience Required: 2–4 years
• Qualification: B.Pharm
• Employment Type: Permanent
• Salary Range: ₹2.4 – ₹3.5 LPA
• Vacancy: 1 Position

Responsibilities
• Preparation of protocols-cum-reports for process validation
• Preparation of cleaning validation protocols and reports
• Preparation of instrument validation reports
• Preparation of personnel validation documents for chemists
• Maintain QMS documentation records
• Prepare and update Batch APQR (Annual Product Quality Review)
• Draft and revise Standard Operating Procedures (SOPs)
• Maintain document control and archival systems
• Support regulatory audits and inspections

Required Qualifications
• Bachelor of Pharmacy (B.Pharm)
• Knowledge of pharmaceutical validation and QMS systems

Educational Requirements
• B.Pharm from a recognized institution

Experience and Skills
• 2–4 years of experience in pharmaceutical documentation
• Experience in validation documentation (process, cleaning, instrument validation)
• Understanding of GMP and QMS compliance
• Strong documentation and report-writing skills
• Good organizational and record management abilities
• Attention to detail and regulatory awareness

Salary Insights
The annual salary for this role ranges between ₹2,40,000 and ₹3,50,000 depending on experience, documentation expertise, and regulatory exposure.

Company Overview
Wings Biotech LLP operates in the prescription and branded formulations segments, focusing on delivering quality pharmaceutical solutions. The company encourages skilled and innovative healthcare professionals to grow within a structured and compliance-driven environment.

FAQs

Q1. Is this a regulatory submission role?
No, the role is primarily focused on validation and QMS documentation.

Q2. Is manufacturing experience preferred?
Yes, experience in pharmaceutical manufacturing documentation is preferred.

Q3. What type of validation exposure is required?
Process validation, cleaning validation, instrument validation, and APQR preparation.

Q4. Is this a permanent position?
Yes, this is a permanent role.

Q5. What is the salary range?
₹2.4 – ₹3.5 LPA depending on experience.

Application Tips
• Highlight validation protocol and report preparation experience
• Mention APQR and SOP drafting expertise
• Showcase QMS documentation handling
• Include audit and compliance support exposure
• Emphasize accuracy, compliance knowledge, and documentation skills