VP, Regulatory Strategy Oncology
Reporting to the SVP of Global Regulatory Affairs the VP and Oncology Regulatory Strategy Head will be responsible and accountable for the definition and execution of the worldwide regulatory strategy for all investigational and marketed products in the Oncology Therapeutic Area, including solid tumor and hematological cancers, and all other Phase 1 and 2 programs in development. Working with the Program Strategy Teams, Global Development Teams, and Global Regulatory Leads, this role will provide regulatory leadership and oversight to the development of global regulatory strategies, provide regulatory guidance, review critical impact documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy by the regions in line with the Program Strategy Team's goals for each of the products. The VP will lead broadly in a cross-functional and multi-cultural environment and leverage their extensive experience to represent regulatory affairs in discussions with senior leadership and Executive Management. The VP will lead and mentor senior leader regulatory professionals across the Oncology portfolio that serve as the designated Global Regulatory Leads and their teams in support of designated programs to address the unmet medical needs of the patients in need of innovative new therapeutic approaches for treatment of a variety of solid and liquid tumors.
- Lead global development and regulatory teams to advance multiple programs in the oncology therapeutic area.
- Leverage deep oncology regulatory experience to provide teams with guidance on innovative approaches informed by regulatory precedent and emergent opportunities
- Preparation and submission of NDA/MAAs for submission within expedited timelines across the regions
- Dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of responses to regulatory questions
- Ensure close alignment between the global regulatory strategy and corporate objectives within the Oncology TA
- Represent the sponsor in key negotiations with regulatory authorities in the US, EU, Japan, China and across regions
- Provide strategic and technical guidance on critical impact regulatory submissions (e.g. responses to major objections raised by regulatory authorities including product labeling)
- Develop and mentor teams to provide project teams with strategic regulatory guidance to expedite product development, registration and through life cycle management
- Impact continued development of regulatory affairs department through leadership and participation on the Global RA Senior Leadership Team
- Partner closely with senior leaders within Oncology Clinical Research, in addition to cross-functional teams within Development and Commercial functions, to develop regulatory strategies in close alignment with business objectives across the Oncology TA
- Works through Global Regulatory Leads to partner ensure alignment in the definition and execution of regulatory strategy across the regions
- Represents global regulatory affairs at the Oncology Development Review Committee (DRC) and provides guidance and direction with impact
- Provides regulatory oversight, strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations and acquisitions
- Leads Global Regulatory Leads and their US Regional Regulatory teams responsible for all INDs, NDAs and lifecycle management within Oncology TA; plans resources and coordinates regulatory activities and communications across the global regulatory matrix
- Leads all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Maintains knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible
- Champions initiatives that contribute to global process improvements which have a significant impact on business
- Advanced scientific degree (PhD, PharmD, MD, MSc) preferred
- 15+ years of overall regulatory leadership experience, including leadership of global teams
- Demonstrated global leadership capability and deep understanding of the oncology therapeutic area ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions
- Is recognized as an Oncology expert resource for regulatory advice internally and externally
- Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues
- Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
- Must be capable of playing the lead role in updating and preparing the company for major changes in legislation which impact across departments
- Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
- Negotiation, influencing, and excellent interpersonal communication skills are required
- Experience in the leadership to lifecycle management of products across oncology therapeutic areas highly desirable
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