Parexel Hiring Remote Senior Regulatory Affairs Associate

opportunity to work remotely as a Senior Regulatory Affairs Associate at Parexel. Learn about the qualifications, responsibilities, and locations available in India, including Remote, Hyderabad, and Mumbai.

About Parexel: Parexel is a renowned consulting firm specializing in helping biopharmaceutical and medical device companies navigate regulatory challenges. Join a dynamic team focused on innovation and collaboration, with opportunities for continuous learning and career growth.

Role Overview: Senior Regulatory Affairs Associate

Qualifications:

• Candidates with 3 to 8 years of experience in handling submissions in varied markets. Experience in handling EU submissions would be preferred.
• Candidates with experience/ in-depth knowledge in handling post approval changes EU markets
• Candidates with working experience in handling RIMS tools. Hands on experience in Veeva Vault tool would be preferred

Responsibilities:

• Handling Life Cycle Maintenance for approved products including but not limited to filing of CMC variations (for small molecule &/or biological finished formulations), Administrative Variations, Renewals, Marketing Authorization Transfers, Manufacturing Site Transfers, Site Name Change variations and Safety &/or labeling changes in varied markets including but not limied to Euprope, ASEAN and Other Regulated markets
• Review of dossiers for EU in eCTD format and International markets.
• Handling Health Authority Queries within predefined time with adequacy and accuracy, Change Control management
• Independently communicate and coordinate with various stakeholders (internal & external) to ensure timely submission of regulatory applications
• Identify gaps in existing business (regulatory) processes and trainings to perform the required tasks and input process improvements to achieve process excellence.

How to Apply: Interested candidates can apply for the Remote Senior Regulatory Affairs Associate position at Parexel through the official job listing

Apply Here