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
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...
Senior Director, Regulatory Affairs Strategy
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 ...
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 Clients s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. The...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics). Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Leadership responsibility for global regulatory strategy to su...
Director, Regulatory Affairs Strategy
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
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...
Sr. Director, Head of Regulatory Law
The Senior Director, Head of Regulatory Law reporting to the VP, General Counsel will provide regulatory counsel to the Rx, Generic, and OTC business at Sun Pharmaceuticals, and its affiliates including Taro Pharmaceuticals. Business partner to R&D, regulatory affairs, and business development teams...
Regulatory Affairs Manager/Sr Manager (Remote)
Pharmaceuticals Quality/Risk Management US Regulatory Affairs. You'll serve as the primary point of contact for all regulatory responsibilities associated with assigned projects and represent regulatory function at cross function discussions. Provide strategic regulatory input to all regulatory proj...
Senior Manager/Associate Director, Regulatory Affairs Strategist
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...