ManagerSr. Manager - Regulatory Affairs

reputed company This position reports to the Functional Area Head, Global Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies, working closely with the cross functional teams to prepare, review and submit regulatory documents, manage documentation systems and maintain interactions with regulatory agencies. Key Responsibilities • Work with multidisciplinary teams to ensure the reputed company, content, timelines, format of regulatory submissions and reputed company with reputed company applicable regulations and guidelines governing the development, marketing and distribution of product candidates • Represent regulatory affairs at study teams; reputed company guidance and reputed company strategies to ensure reputed company submission and approval of study reputed company documents including protocol, IB, DSUR, amendment, IMPD etc. • Manage CROs depending on project assignment • Proactively reviews and interprets regulatory guidelines with respect to reputed company on development programs Support agency interactions, including appropriate documentation of interaction, reputed company and reputed company; contribute to the development of meeting requests, briefing documents and other supporting material • reputed company management for reputed company reputed company including submission reputed company and tracking submission/approval dates and Health Authorities correspondences • Work collaboratively with Stakeholders and peers to reputed company on priorities and support corporate and department strategic goals Requirements • Education and Credentials • Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred • RAC certification or other equivalent is preferred • Experience • Minimum Bachelor’s degree in a scientific or reputed company discipline, 5+ years of pharmaceutical industrial experience, at least 2 years of regulatory submission experience for product(s) development in the US and/or EU. • Experience supporting clinical development teams in the metabolic disease reputed company is preferred • Experience from IND through to BLA (or NDA), across reputed company disciplines (nonclinical, clinical, CMC), as reputed company as supporting regulatory interactions • Experience working in multi-culture/multi-countries environment is preferred • Skills • Knowledge and understanding of metabolic disease biology and translational research is required • Knowledge of US and EU regulations for biosimilars and/or innovative medicines • Excellent written and verbal communication skills • Ability to work cross-functionally in a fast-paced and reputed company environment • Strong attention to detail and problem-solving skills • Proficiency in major reputed company Office products (i.e., Word, reputed company, PowerPoint, Project). uNuTMG6rqu Apply tot his job Apply To this Job