美国加州/马里兰招聘RA VP-Oncology

吴红岩医药荐客 2022-01-04

汇报给全球RA Senior VP,组建和管理美国的团队

底薪+bonus+stocks

工作地可选加州或马里兰，疫情期间，可以在家办公。

主要负责肿瘤等三个领域的工作

Duties:

Partner with and mentor the Regulatory Leads aligning on global innovative regulatory strategies for products.
Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
Represents the regulatory interest of the Company by meeting with regulatory agencies
Effectively communicates and implements determined regulatory strategy with the appropriate departments and/or employees.
Works to minimize regulatory issues and helps prevent unnecessary regulatory delays
Will train staff in the preparation of documentation for regulatory review in technical areas, and performs regular evaluation
Ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractors
Perform record review to assure quality submission of regulatory documents
Critical analysis and assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
Define and drive disease area global regulatory policies and priorities.
Lead budget management, resource planning and recruitment of staff.
Review and approve documents for global regulatory submissions as well as core prescribing information.
Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practices and knowledge and using existing tools.

Qualifications:

PH.D. in life sciences and/or science related field and/or other appropriate knowledge/experience.
15+ years of regulatory experience in the pharmaceutical / biotechnology industry
Significant drug development experience.
Oncology therapy area knowledge/experience.
Experience in global regulatory strategy and submissions that have progressed through to registration.
Must have direct hands-on experience preparing and filing IND, NDA & BLA submissions and representing Company to FDA and other international regulatory agencies
Extensive knowledge of US and global regulatory requirements
Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD). •
Must have thorough understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting.
Must possess the understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA.
Must have excellent PC, written and verbal communication skills.
Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment
Strong leadership skills, team player, problem solver, strategic thinker and excellent collaborator
Experience in managing people in a matrixed organizational structure.
Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities.
Ability to travel domestically and internationally