This position will develop and translate regulatory requirements into regulatory strategies, objectives, policies and programs pertaining to the development of new products in the US and other emerging markets. This role will have primary responsibility for activities pertaining to regulatory strategy and submissions to the FDA and other Health Authorities. This role will provide support of global registration, which will include internal and external client and regulatory authority liaison. Excellent technical, verbal and written communication skills are required. The position will include the supervision and management of regulatory professionals and support personnel.
Essential duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Responsible for managing and leading activities of RA with emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities.
Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support registrations, including preparation and maintenance of IND, NDAs, CTAs, ANDAs, NADA and ANADAs.
Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Lead and facilitate activities, including team preparation, for meetings with FDA, EMA, and other regulatory authorities
Manage the regulatory aspect of the pediatric program and development activities internally for NDA products.
Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
Single point of contact and accountability for regulatory strategy and will represents regulatory on key internal decision-making product teams.
Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs.Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to ARI staff
Provides direction to senior managers in various areas and/or groups. Recognized as an influential leader.
Qualifications and Requirements
BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare required.
Minimum of 8 years of experience working in the pharmaceutical/biotechnology industry with direct extensive experience in Regulatory Affairs; Regulatory Affairs Certification (RAC) a plus.
Minimum of 8 years of leadership experience required. Desirable to have been trained in a large pharma or biotech company and subsequently also found success in a small company to leverage his/her learnings.
Proven ability to manage and direct multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities.
Chemistry, Manufacturing and Controls (CMC) regulatory affairs and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, and life cycle management.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Employer will assist with relocation costs.
Internal Number: 2890
About American Regent, Inc.
American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.