Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.
Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.
ResponsibilitiesDevelop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country regulatory requirementsStrong project management skills and strong interpersonal skills to handle complex distributed programsAbility to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messagingWork closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are alignedBe the point of contact between the company and the regulatory agency serve as the regulatory liaison for the company QualificationsMaster’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory;
PhD or PharmD in above disciplines are preferred10+ years industry experience a must with RA novel drug developmentCMC and / or Botanical experience, RAC certificationThorough understanding of ICH and US CFR requirements and regulations.
Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)Regulatory agency direct interaction experienceStrong communications skills
Sr. Director, Regulatory Affairs Strategy
Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned. Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executi...
Sr. Director, Regulatory Affairs Strategy
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Director, US Regulatory Affairs Strategy
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Sr. Director, Regulatory Affairs Strategy - Sun Pharmaceutical Industries, Inc.
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Director Regulatory Affairs
The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. The ...
Associate Director, Regulatory Affairs, Advertising & Promotion—New Jersey
Represents Regulatory Affairs on the company’s Promotional Review Committee and provides guidance on current regulatory environment and regulatory considerations that may impact business activities. Associate Director, Regulatory Affairs, Advertising & Promotion—New Jersey. Tanner and Associates...
Senior Director, Regulatory Affairs Strategy
In this role, the regulatory leader will be primarily responsible for the development of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab’s portfolio of development and marketed drugs. Genmab is looking for an experienced and passionate leader to be a part...
Director, Oncology TA Global Regulatory Affairs Strategy Lead | Growing $1.5Bn Pharma | NYC Metro area (hybrid) | RETAINED SEARCH
Regulatory Affairs experience, with an emphasis in Oncology and demonstrated experience defining and leading clinical-stage regulatory strategy. DIRECTOR, ONCOLOGY TA GLOBAL REG AFFAIRS STRATEGY LEAD. SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech. Medical Directors (Director/SD...
Global Regulatory Strategy, Associate Director
Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentraliz...
Director, Medical Affairs Strategy - Hematology
Reporting to the Global Medical Affairs Strategy Lead (MASL), the Medical Director will be the subject matter expert responsible for providing medical support to the development and execution of the Global Medical Affairs strategic and tactical plans and support the Global medical launch planning, a...