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About Company

Together, we’re on a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. This mission bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means collaborating with the world’s leading manufacturer of generic medicines and the proud producer of many 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 join us on this mission.

Position Name :

Regulatory Affairs Associate III

Organization :

Teva Pharma

Qualification:

M.Sc, M.Pharm

Experience:

7-8 years

Salary:

75,000 - 85,000 /month

Location:

Navi Mumbai, India, 400706

This position provides medical and scientific expertise for regulatory submissions and involves in-depth expertise within medical science. The primary goal is authoring clinical and non-clinical expert reports and summaries supporting new submissions of Teva’s portfolio (Generics, Innovative, and Medis organizations) in international markets (IM). This role involves working with cross-functional, multidisciplinary teams to facilitate the preparation of regulatory documents including protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications.

How You’ll Spend Your Day:

  • Plan, author, review, and coordinate various regulatory documents.
  • Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust document content as required based on internal/external input, and prepare final versions.
  • Lead briefing book preparation to support HA meetings for innovative products, including process planning, authoring, and comment resolution meetings (CRM).
  • Perform searches and reviews of relevant literature references related to efficacy, safety, and drug-drug interaction studies in line with SmPC of the reference product across various therapeutic areas.
  • Prepare scientific overviews based on available literature and in line with regulatory requirements in the format of clinical and non-clinical expert reports and summaries to support Gx product regulatory submissions; prepare document updates as needed.
  • Conduct editorial reviews of documents for grammar, punctuation, and submission-compliant formatting (TACT templates).
  • Act as a cross-functional focal point for medical affairs issues raised through deficiency letters of Gx and innovative products in IM; write high-quality responses supported by literature findings.
  • Contribute to routine lifecycle management activities for a cross-section of products – Generics, Biosimilars, as well as innovative products.
  • Collaborate with colleagues in Regulatory Affairs, R&D, and other departments as required.
  • Perform duties under minimal supervision if remotely located.
  • Maintain and enhance knowledge of regulatory guidelines, international regulations, and guidance associated with regulatory document preparation and submissions.

Your Experience and Qualifications:

  • Master’s degree in life sciences or related scientific discipline with at least 7-8 years of pharmaceutical industry experience, including some regulatory writing experience.
  • Qualification and experience for being a final signatory for scientific expertise.
  • Ability to independently interpret and present scientific and medical information.
  • Proficient in the use of Microsoft Office tools.
  • Excellent knowledge of the English language (oral and written).
  • Strong communication and interpersonal skills (oral and written).
  • Ability to work both independently and in cross-functional teams.
  • Task-oriented with the ability to work according to targeted timelines.
  • Well-organized and self-disciplined with good planning skills.
  • Good understanding of drug development.
  • Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.

Reports To: Director of Regulatory Affairs

Application Link

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