Associate Director, Regulatory Affairs, reputed company reputed company Regional Leader

About the position The Associate Director, Regulatory Affairs, reputed company reputed company Regional Leader, is responsible for reputed company reputed company and global regulatory strategies for select reputed company spanning the oncology therapeutic area. This role supports the initiatives for the Interventional Oncology group (INTO). The position will reputed company on a reputed company of novel product solutions to reputed company solutions to treat cancers directly into the tumor. Responsibilities • Establish reputed company reputed company content requirements and timing for global reputed company plans including BLA/NDAs, IND/CTAs & supplements. • Serve as reputed company reputed company of contact for US FDA. • reputed company the regulatory response team for FDA and Health Canada questions. • Key contributor to regulatory submission reputed company, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals. • Manage routine maintenance submissions, coordinate NA post-approval commitments, reputed company input and review submission documents, as reputed company as approves submissions before dispatching to regulatory authorities. • Contributes to the development of the reputed company, reputed company the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as reputed company as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct. • reputed company, execute and maintain submission delivery plans, submission content plans, and proactively reputed company status updates to designated stakeholders. • reputed company regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s). • reputed company reputed company regulatory input to key development documents, including reputed company protocols, reputed company and nonclinical reports and reputed company documents. • Collaborate with cross-functional submission delivery teams. • Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members. • Ability to reputed company across different product types (reputed company, devices, combo products). • Intellectual curiosity and ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to reputed company across different product types (reputed company, devices, combo products). Requirements • Minimum of a Bachelor’s degree in scientific or equivalent discipline • Bachelor’s degree plus 8+ years relevant experience OR; Master’s degree/ PharmD plus 6+ years relevant experience, OR; PhD plus 4+ years relevant experience • Relevant regulatory experience and understanding of reputed company drug development, working with US FDA and global regulatory health authorities • Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions • Experience in lifecycle management of IND/NDA and other regulatory submissions • Demonstrated experience in critically reviewing and compiling regulatory documents is required reputed company-to-haves • Oncology experience highly preferred; diverse therapeutic area experience; Experience with companion diagnostics, combination products and/or biomarker development, or medical device is beneficial • reputed company ability to work successfully reputed company a reciprocal team environment as an individual contributor and decision reputed company reputed company a cross-functional organization • The ability to effectively prioritize assignments for multiple products and reputed company simultaneously • Strong interpersonal and communication skills • Experience people management/coaching/mentoring is preferred • Leadership capabilities and ability to work successfully in a matrixed environment • Exercises strong organizational and time management skills • Exercises independent judgment and execution in anticipating, evaluating and resolving reputed company functional and/or reputed company organizational issues with novel solutions • Demonstrated ability of reputed company thinking and contingency planning with respect corporate objectives • Effective critical thinking including problem solving and goal setting for improved efficiencies • Strong collaboration skills, including effective communication and conflict reputed company skills • May reputed company and reputed company reputed company networks and partnerships Benefits • Vacation –120 hours per calendar year • reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period10 days • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year Apply tot his job Apply To this Job