The Director of Regulatory Business Development is responsible for the regulatory scientific assessment, due diligence activity, preparation of development strategy and scenarios, preparation of risk/gap assessment and mitigations, and the preparation of regulatory assessments and recommendations supporting external business development activities. The position is responsible for supporting all aspects of the Business Development and Acquisition strategy that involves Regulatory activities, including: 1) proactively identifying potential new business opportunities, 2) participating and leading cross-functional teams to conduct thorough evaluations of new business opportunities, 3) formulating recommendations and development scenarios related to Regulatory Affairs aspects for executive management consideration, and 4) participating in negotiations and ensuring timely execution of legal agreements with external parties. This role serves as the primary GRS interface with Business Development, Search and Evaluation, Research and Development, Global Manufacturing and Supply Chain and Commercial Development organizations for the purposes of scientific assessment, due diligence activities, development plan generation, financial modeling support, and contract creation and finalization. The Director, Regulatory Business Development ensures business needs are met by anticipating, identifying, prioritizing and communicating regulatory risks, as well as developing R&D scenarios to address and mitigate the risks associated with candidates undergoing evaluation. This role supports regulatory activities associated with business transactions including in-licensing and out-licensing, co-development/collaborations, acquisitions of new chemical or molecular entities including advanced, tissue, and cell-based therapies, platform technologies, marketed products, and company acquisitions to further the company’s overall strategic business development objectives.
- Responsible for preparing oral and written regulatory scientific assessments for potential in-license/out-license, R&D co-development/collaborations and all company or asset acquisitions based on face-to-face and virtual meetings with external companies/representatives, and confidential and public data review for identified compounds, companies, or entities
- Responsible for preparing GRS evaluations and recommendations for venture investment opportunities of new and emerging platform technologies
- Responsible for leading GRS activities supporting the out-license/divestiture of AbbVie development stage compounds or marketed products to external business partners
- Responsible for developing the regulatory strategy and inputs into future development plans, commercialization, and targeted product profiles (or aspirational product concepts) for candidates undergoing evaluation for financial modeling purposes. The evaluation includes a first pass resource need assessment
- Responsible for incorporating and negotiating the regulatory activities, specifications, and requirements that are in alignment with the planned development scenario and deal model/structure within the final contract and agreement
- Responsible for timely delivery and accurate communication, decision making and recommendations for regulatory scientific assessments to all levels of GRS and R&D management and leadership. Directly interacts and communicates with key internal and external stakeholders (see below for examples) across all phases of the business development process (i.e. scientific assessment, due diligence, meetings with company, internal debriefs/decision-making meetings, alliance management meetings)
- Thoroughly understands current global industry and key country/region regulatory environments (e.g., US, EU, Japan, China, etc.), guidelines/guidance and trends, pharmaceutical drug development across multiple therapeutic areas, key global pharmaceutical and health care initiatives, and competitive landscape and intelligence to support the regulatory assessment, identification of regulatory risks and mitigation plans, and recommendations for the identified compounds or companies
- Responsible for seeking or obtaining internal or external consultant resources to provide specialized expertise as needed to support opportunity assessments. Intimately knowledgeable of the broad AbbVie organization and is able to obtain accurate information in efficient manner.
- Manages both indirectly and directly internal regulatory resources and consultants identified with specific needed expertise to support peak activity levels
- Manages regulatory budget and operating expenses associated with due diligence and external consultant spend
- Responsible for development and implementation of standard processes, templates and communication tools to be used for the scientific assessments and reports used to communicate regulatory, quality, and safety risks and recommendations; responsible for program transfer of executed business opportunities within internal Regulatory teams