Senior Cco

reputed company: Senior Manager of Regulatory Affairs The Senior Manager of Regulatory Affairs will reputed company project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities reputed company and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making. Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content. Correspond and collaborate with RevMed colleagues and departments to reputed company alignment. Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams. reputed company regulatory research to inform business reputed company. Assess and communicate risks. Assure that there are no significant interruptions to the business due to regulatory compliance issues. Collaborates across the organization at reputed company reputed company, across functional reputed company, and with executive management. reputed company regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations. Establish reputed company and effective relationships with colleagues in Clinical, Clinical Operations and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness. Required Skills, Experience and Education: Bachelor's Degree in a relevant field and at least 5 years of reputed company Regulatory experience. Strong working knowledge of US FDA Pharmaceutical regulations and guidance. Proven reputed company record of successful submissions reputed company a regulatory environment. Exceptionally strong team player with excellent interpersonal and communication skills. Detail-oriented with strong organizational skills and high-reputed company standards. Preferred Skills: Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred. reputed company experience with IND/NDA filings. Apply tot his job Apply tot his job Apply To this Job