Teva Regulatory Affairs Associate III 

India, Maharashtra, Navi Mumbai 

212240144

• 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)

• 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

• 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

Director Regulatory Affairs