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Teva Pharmaceuticals Sr Mgr Regulatory Affairs in Navi Mumbai, India

Sr Mgr Regulatory Affairs

Date: May 20, 2024

Location:

Navi Mumbai, India, 400706

Company: Teva Pharmaceuticals

Job Id: 56005

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.

The opportunity

  • Act as Project manager (PM) overseeing the support for new registrations using Teva’s proprietary products and achieving Marketing Authorisation (MA) for the Medis business.

  • Focus on specific territories such as LATAM, Canada, China etc.

  • Take responsibility for planning, preparing, submitting and supporting Marketing Authorisation Applications (MAAs) to Medis clients.

How you’ll spend your day

  • Evaluate dossier suitability for specific territories.

  • Regulatory strategize, prepare and submit MAAs to Medis clients.

  • Engage actively and provide extensive support to Medis clients to facilitate MA approvals.

  • Coordinate and contribute to responses to deficiency from health authorities and act as primary liaison between R&D, Site RA, Clinical team, Medis clients and other relevant functions.

  • Monitor timelines and coordinate the flow of information internally and externally throughout the registrations process until MA approval is obtained.

  • Offer regulatory guidance and support to Medis.

  • Maintain databases and other document management systems/lists.

  • Contribute to specialized projects as directed by Medis RA managers.

  • Organize dossier audits and due diligence for clients.

  • Provide regular status updates to management.

Your experience and qualifications

  • B.Pharmacy/M.pharmacy/Msc in chemistry.

  • 12 to 18 years of experience in Regulatory Affairs

  • Expertise in global regulatory strategies.

  • Strong skills and in-depth understanding of regulatory environments across various regions including LATAM, Canada, China, etc.

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.

EOE including disability/veteran

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