Vice President, Regulatory Affairs Consulting

Synteract - USA - VP Regulatory Affairs Consulting - US or UK Office-based or Remote-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Specific tasks would include: Drive opportunities for regulatory and clinical strategic consulting activities. Provide strategic regulatory and clinical input to other departments and management (proposal development and project execution oversight in the field of regulatory and clinical consulting). Represent the company and department externally on relevant occasions as well as attendance of bid defense meetings. Support and/or lead key regulatory and clinical departmental initiatives. Build relationships to existing and future clients. Provide direction of the department in the hiring, mentoring, professional development and performance management of the staff. Ensure execution of cross-functional and global corporate goals. Lead clinical strategy through development of the study synopsis with identification and coordination with necessary resources and input from other departments (e.g., biostatistics, medical affairs, pharmacokinetics). Lead regulatory/health authority meetings for clients. Act as key point of contact for regulatory agencies/health authorities for clients. Oversight of Regulatory submissions for early, late and approved products. Prepare (write, review, edit) independently, regulatory documents for submission to regulatory agencies/health authorities. Qualifications: Bachelor's or Master's degree with a scientific background and a minimum of 15 years applicable industry experience or equivalent combination of education and experience. At least 8 years of management experience. Excellent working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. Expert knowledge of CRO or consultancy business with emphasis in delivering with a high level of quality, on time, and on budget. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.... - Permanent - Full-time

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