Regulatory Affairs Associate III

3 weeks ago

Navi Mumbai, India Teva Pharmaceuticals Full time

The opportunity

This position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of 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). Able to work with cross-functional, multidisciplinary teams to facilitate preparation of regulatory documents (including, but not limited to, 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 content of document as required based on internal/external input, and prepare final version. Lead briefing book preparation to support HA meetings for Innovative products, including process planning, authoring, comment resolution meeting (CRM). Performs search and reviews relevant literature references related to efficacy, safety, drug-drug interaction studies, etc. in line with SmPC of the reference product (various therapeutic areas). Prepares scientific overviews based on the available literature and in line with the regulatory requirements in the format of clinical and non-clinical expert reports and summaries to support Gx product regulatory submissions; prepares a.m. document updates. Editorial reviewing of documents for grammar, punctuation, and submission-compliant formatting (TACT templates). Cross-functional focal point for medical affairs issues raised through deficiency letters of Gx and innovative products in IM; writing high quality responses supported by literature findings. Contributes to routine lifecycle management activities for a cross section of products – Generics, Biosimilars as well as innovative products. Collaborates with other colleagues in Regulatory affairs, R&D and other departments as required. Ability to perform 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 including some regulatory writing experience. Qualification and experience for being final signatory for scientific expertise. Ability to independently interpret and present scientific and medical information. Proficient in use of Microsoft Office tools Excellent knowledge of 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, 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

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