Cipla Mumbai Job: Team Member – Regulatory Affairs (US Market)

Cipla, a renowned pharmaceutical company, is seeking a talented Team Member in Regulatory Affairs for the US market in Mumbai, Maharashtra, India. Cipla is committed to delivering high-quality healthcare solutions globally, and this role offers a unique opportunity to make a significant impact on regulatory affairs for the US market.

Vacancies List:

• Company Name: Cipla
• Company Address: Mumbai, Maharashtra, India
• Position Title: Team Member – Regulatory Affairs (US Market)
• Role: Team Member – Regulatory Affairs
• Department: Regulatory Affairs
• Industry Type: Pharmaceutical
• Employment Type: Permanent
• Role Category: Healthcare

Job Description:

As a Team Member in Regulatory Affairs at Cipla, you will be responsible for ensuring the timely submission of product dossiers and deficiency responses to regulatory authorities. Your role involves collaborating with cross-functional teams and external stakeholders to facilitate query response discussions and to ensure that products are approved and launched within stipulated timeframes.

Key Responsibilities:

1. New Product Submission
   • Prepare, review, collate, and compile documents for timely dossier submission.
   • Coordinate with cross-functional teams for query response discussions.
   • Verify pre-approved documents and ensure compliance with eCTD requirements.
   • Prepare M1-M5 documents and collate dossier/deficiency response packages for submission.
   • Support regulatory strategy and annexure preparation.
   • Prepare controlled correspondences and meeting requests.
2. Post Approval Activity & Customer Support
   • Submit post-approval supplements to enhance productivity and product quality.
   • Verify pre-approved documents and variation packages.
   • Prepare M1 documents and collate variation packages and annual report packages for submission.
   • Manage labelling updates and prepare labelling submission packages.
   • Prepare SPL and Drug listing for customer/launch products.
   • Provide approved product information and relevant documents as requested.
   • Support due diligence activities.
3. Pre-Launch Activity Support
   • Compile and submit PLAIR applications.
   • Conduct gap analysis review for near-approved/pre-launch products.
4. Database Management
   • Update various databases related to regulatory affairs.
   • Notify teams and stakeholders about approvals and approved documents.
   • Include and update registration details in databases.
   • Provide details for APQR compilation.

Education Qualification: M.Sc/M.Pharm

Relevant Work Experience: 3 to 6 years of experience in pre-approval for the US market.

Job Location: Vikhroli, Mumbai