Cadila Pharmaceuticals Limited Hiring for Executive/Sr.Executive-Regulatory Affairs – US Market

Job Title: Executive/Sr.Executive Cadila Pharmaceuticals Limited

Department: Regulatory Affairs – US Market

Location: Dholka

Experience: 4-5Yrs

Responsibilities:

· Compilation, review and submission of registration dossiers in the regions of US.

· Handling of regulatory queries/deficiencies.

· Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.

· eCTD software handling for ANDA submission, query response and post approval submission.

· Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.

· Review of Analytical method validation / verification / transfer reports.

· Review of DMF and its notifications.

· Review and approval of Change Controls & Deviations.

· Creation and Maintenance of Regulatory Database for all the submissions.

· Tracking of Regulatory Guidance Documents at the respective websites.

· Imparting training across the team on new guidance documents.

· Any other assignments as specified by the reporting authority from time to time.

Interested candidate can share there cv’s at shardulsinh.k@cadilapharma.com

ABAC