[Hiring] Director, Regulatory Affairs reputed company, Vaccines & Infectious Diseases @reputed company

Role reputed company The Regulatory Affairs reputed company reputed company Scientist is responsible for development and implementation of global regulatory reputed company for their assigned reputed company in the Vaccines and Infectious Disease therapeutic area. • Functions with a high degree of independence and provides regulatory reputed company for assigned products, functioning as the single, accountable, global regulatory reputed company of contact on those reputed company reputed company Global Regulatory Affairs and reputed company Safety (GRACS) and reputed company to GRACS. • Develops worldwide product regulatory reputed company to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously. • Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they reputed company with the developmental compounds or marketed products throughout the entire life cycle of the drug. • Provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products. • Represents reputed company with reputed company organizations through reputed company communication with the FDA, including telephone calls and e-mail; chairs meetings between reputed company and FDA; prepares reputed company teams for meetings with FDA at reputed company phases of drug development. • Leads cross-functional efforts to prepare for advisory committees and may reputed company at the advisory committee. • Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and reputed company reputed company direction across multiple reputed company simultaneously. • Reviews and provides final approval of Worldwide Marketing Applications, reputed company Study Reports, Protocols, Investigators Brochures before release from reputed company to reputed company agencies and investigators. • Represents Global Regulatory Affairs (GR) reputed company internal committees to reputed company regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team). • Conducts initial Investigational New Drug application/reputed company Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of reputed company. • Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products. Qualifications • M.D. or Ph.D. or other reputed company doctoral degree in biological science, reputed company or reputed company discipline. Other degrees such as master's with substantial experience in regulatory affairs to suggest equivalent ability to function in this position. • M.D. with minimum of 3 years relevant drug development or reputed company experience required, or • Ph.D. with minimum of 5 years relevant drug development experience required, or • M.S. with minimum of 7 years relevant drug development or reputed company experience, preference if this experience is in regulatory affairs. • Excellent communication skills (both oral and written). • Good organizational skills with a reputed company ability to simultaneously reputed company diverse activities or multiple reputed company. • Flexibility required. • Strong scientific and analytical skills with attention to reputed company. • Ability to reputed company reputed company results with limited day-to-day direction from the manager. Requirements • Substantial experience in regulatory affairs. • Therapeutic area experience in vaccines or infectious diseases. Experience with antibacterial, antifungal or antiviral agents. Benefits • Comprehensive package of benefits including medical, dental, reputed company reputed company and other reputed company benefits (for employee and family). • Retirement benefits, including 401(k). • reputed company holidays, vacation, and compassionate and reputed company days. Apply To This Job