Regulatory Affairs Associate II

4 weeks ago

Goa, India Teva Pharmaceuticals Full time
Who we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.How you'll spend your day
  • 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.
Your experience and qualifications
  • 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.
Reports To

Sr Manager - Regulatory Affairs

Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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