Regulatory Affairs Pharmacist/Scientist at Cipla

Job Purpose

• Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the dossiers, post-registration variations and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per overall objective of Cipla Medpro.

Accountabilities
 CDT/New dossier submissions and approvals: Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.

• Completes dossier audits/due diligences and Regulatory Affairs (RA) strategies as required.
• Complete specific pre-registration activities including receipt, screening, compilation and timeous submission of new dossiers, P&A, Clinical and Naming & Scheduling responses to the Relevant Health Authority in line with the latest regulatory guidelines and in accordance with specific timelines committed to.
• Abide by the required standards, protocols and processes around obtaining dossiers and gathering supporting data from third party holders after signing of supply / purchase / financial agreements.
• Complete any required internal due diligences and risk reports to determine gaps ahead of time, and ensure that proper steps are taken, to proactively solve challenges in the registration process. This will ensure no delay at launch stage.
• Prepare new dossier submissions in paper and/or e-CTD systems, as required.
• Ensures timely identification of Regulatory Intelligence (RI) and appropriate impact assessment for RA and impacted departments as required. (Refer to point 5 section IV)

Education Qualification

• B. Pharm or BSc. or higher post graduate scientific degree

Relevant Work Experience

• Minimum 1-2 years’ experience in a Regulatory Affairs Assistant role or similar, in the regulatory function covering all areas.
• Attention to detail, Resilience, Collaborative approach, time-management, good communication skills, team player; experience in e-CTD submissions

Competencies/Skills

• Responsibility Centered
• Purpose Inspired
• Excellence Focused
• Innovation Driven
• Integrity and Trust Anchored