Plant Head-DRA Compliance

We are looking for a dynamic and experienced Plant Head – DRA Compliance to oversee the overall operations of the plant with a strong focus on Drug Regulatory Affairs (DRA) compliance. The ideal candidate will ensure that all manufacturing, quality, and regulatory processes meet national and international standards while driving operational excellence.

Key Responsibilities:

• Lead and manage plant operations ensuring regulatory compliance with national and international guidelines .
• Oversee the preparation, review, and timely submission of regulatory dossiers and ensure compliance with product registration requirements.
• Coordinate with Quality Assurance, Quality Control, Production, and Regulatory Affairs teams to maintain a state of compliance across all functions.
• Monitor and implement changes as per updated regulatory guidelines to ensure continuous compliance.
• Handle regulatory inspections, audits, and client visits and ensure all CAPA are effectively addressed.
• Drive plant performance through operational efficiency, safety, quality, and productivity.
• Develop and mentor cross-functional teams to strengthen compliance and regulatory awareness.
• Maintain robust documentation and reporting systems to meet compliance and audit readiness.

Candidate Requirements:

• Master’s/Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related fields.
• Minimum 9–10 years of experience in pharmaceutical plant operations with a strong DRA compliance background.

Job Types: Full-time, Permanent

Pay: ₹80,000.00 - ₹100,000.00 per month

Ability to commute/relocate:

• Baddi, Himachal Pradesh: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Regulatory Affairs : 9 years (Required)
• injectables: 9 years (Required)

Work Location: In person