Teva Pharmaceuticals is hiring B. Pharma/ M. Pharma as a Regulatory Affairs Associate II – Apply Now

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Take the next step in your pharmaceutical career journey with Teva Pharmaceuticals! We’re thrilled to announce a fantastic opportunity for skilled professionals in Regulatory Affairs. Teva Pharmaceuticals is currently seeking talented individuals with B. Pharma or M. Pharma qualifications to join our team as Regulatory Affairs Associate II. If you’re passionate about ensuring the safety and efficacy of pharmaceutical products and eager to contribute to global health, this could be the ideal role for you. Don’t miss out on the chance to grow your career with a renowned industry leader like Teva Pharmaceuticals. Apply now and embark on a fulfilling career path!

Job Title: Regulatory Affairs Associate II

Educational Qualification: B. Pharma OR M. Pharma

Experience: 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.

Roles and Responsibilities

• 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 regulatory submissions.
• 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 address deficiencies.
• 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 administrative documentation.

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