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