Position: Assistant Manager – Regulatory Affairs (Europe)
Location: Corporate Office, Greater Noida

Job Responsibilities:

1. Europe/Australia/Canada:

• Author, review, and submit drug product dossiers for EU, UK, Australia, and Canada.
• Manage product life cycle activities and assess post-approval changes.
• Publish eCTD documents.
• Possess thorough knowledge of CMC and Module 1 requirements.

1. Preparation & Submission:

• Author, review, and submit new dossier applications, variations, renewals, and RFIs for EU (DCP/MRP/NP), UK, Australia, and Canada Health Authorities.
• Author Module 1 and quality modules.
• Assess post-approval changes and maintain life-cycle regulatory activities.
• Coordinate with cross-functional teams to plan and complete regulatory filings.
• Review and finalize artwork/labels per current QRD guidelines.
• Stay updated on technical guidelines, regulatory requirements, and trends.
• Publish eCTD documents.

1. Coordination:

• Interface with R&D and other business functions to ensure timely project-specific regulatory strategies.
• Coordinate with API vendors to resolve regulatory technical queries.
• Review technical documents such as process validation, AMV, stability, and composition against DMF/dossier requirements.

1. Reporting & Maintenance:

• Maintain regulatory files and databases.

Qualifications:

• Education: Master’s or Bachelor’s degree in Pharmacy
• Certifications (Preferred): PGDRA
• Experience: 3-10 years in Dosage Regulatory Affairs for regulated markets, with at least 5 years post-qualification.

If you are a proactive professional with a strong background in regulatory affairs, especially within the EU, UK, Australia, and Canada markets, we invite you to apply for this dynamic role.