About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
• Reports to WSR-Oncology Regulatory Global Regulatory Portfolio Lead
• Serve as US, EU and/or Global Regulatory Lead on multifunctional project teams in the oncology therapeutic area, providing regulatory input to teams.
• Work with teams to develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages.
• Manage regulatory aspects of projects, including the preparation and submission of correspondences and applications to regulatory agencies.
• Act as direct liaison with FDA or EMA to facilitate the prompt review and approval of applications.
• Understand regulatory environment and communicate priorities to stakeholders.
• Accountable for leading or contributing to the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects.
• Partner with project teams and other customers (e.g., Oncology Research Unit, the company Oncology, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, CTAs, NDAs, MAAs, sNDAs, etc.) meet business needs and are provided within agreed time, cost and quality standards.
• Develop and maintain constructive working relationship with Health Authority contacts.
• May represent the company on relevant Trade Association networks or activities.
• Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated.
• Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
• Ensure business compliance, and implementation of and adherence to regulatory standards.
• BS; higher degree advantageous
• 8+ years relevant experience and prior oncology drug development experience preferred. Immuno-oncology experience beneficial.
• Examples of delivery with demonstrable contribution in Regulatory, including knowledge of IND/CTA, NDA/MAA and other submission processes. Global experience desirable.
• Ability to manage regulatory issues.
• Proven ability to consistently deliver within time, cost and quality standards.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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