Teva Regulatory Affairs Associate II 

India, Goa 

196984184

• Assess submission documentation in consideration and compliance with the regulatory requirements and to provide inputs to cross functional teams.
• Coordinate (on need basis) with external parties and cross functional teams to obtain essential scientific data and documents required for regulatorysubmissions.
• Responsible to compile the CMC (m2 & m3) dossier and post approval supplements (on need basis) primarily for EU, also further supporting other Ex-North America filings in CTD format as per the submission timelines.
• Support due diligence process pre-filing and implement action plan to addressdeficiencies.
• Handling of Deficiency letters from regulatory authority’s until product approval
• Escalate key issues to management (risk of delays to submissions, risk to approvability, complex supporting data requirements)
• Assist submissions team with CMC related m1 administrativedocumentation.

• Graduation/ Post graduation in Science/ Pharma discipline
• Minimum 3+ Yrs in core pre-approval regulatory activity in EU and allied markets for Solid Oral Dosage forms. Preference for additional experience in formulation/ analytical development.

Sr Manager - Regulatory Affairs