About the Role:
Provides project leadership support for the overall regulatory department with process development/improvement activities to support organizational optimization and more consistent and seamless interaction with internal and external stakeholders. Works closely with all Regulatory depts. as well as cross-functionally and with external partners and CRO's. Will Work closely with the Regulatory leadership to prepare regulatory submissions (authoring, timeline planning, etc.). Develops and maintains department regulatory processes. Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Takes the lead to recommend and implement changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Your Contributions (Include, But Are Not Limited To):Provide project leadership to develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed Provide regulatory representation and expertise on cross-functional product development teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs Develop and manage project timelines for regulatory submissions. Lead, coordinate, author, critically review and provide strategic input on regulatory filing documents Lead the regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams Develop and implement standard operating procedures and department working practices Ensures the company is adhering to all applicable government regulations Interface directly with US and international regulatory authorities on specific projects when required Lead or partner with team members to complete assigned activities with the project team Mentor or train less experienced colleagues to provide an example of innovation and excellence Contribute to the development of strategic Regulatory plans and processes Other duties as assigned
Requirements:
BS/BA degree in Life/Health Sciences AND 8+ years of progressive industry experience of which a minimum of 6 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity. Experience with FDA regulations and ICH guidelines for regulatory submissions. ORMaster's degree in Life/Health Sciences preferred AND 6+ years of related experience Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals Expert level knowledge of FDA regulations and ICH guidelines for regulatory submissions Demonstrated understanding of laws, regulations, standards, and guidance governing drug development, ex-US regulatory knowledge a plus
