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...
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 - 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, Global Regulatory Affairs Strategy Lead - Oncology (multiple assets) | $7Bn mkt cap biotech | Hybrid | RETAINED SEARCH
DIRECTOR, GLOBAL REG AFFAIRS STRATEGY LEAD - ONCOLOGY. SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech. Medical Directors (Director/SD/ED levels) in Translational Medicine / Clinical Development / Medical Affairs / Drug Safety: 75+ retained assignments. This hybrid role will lead...
Sr. Director, Regulatory Affairs Strategy
Responsibilities Develop and execute novel drug regulatory strategy Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements Strong project management skills and strong interpersonal skills to handle complex distributed programs Ability...
Director, Regulatory Affairs Strategy - Oncology
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Director, Global Regulatory Affairs
Effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencie...
Director, Regulatory Affairs Strategy - General Medicine
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
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, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...