Director, Regulatory Affairs Business Development

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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

Qualifications

• Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
• Preferred Education: Relevant advanced degree is preferred. Certification a plus.
• Required Experience:7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US & Canadaregion.Proven 5+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams. Experience interfacing with major government regulatory
• Required Experience cont'd:Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies
• Preferred Experience:10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen. Familiarity with device regulations
• Note: Higher education may compensate for years of experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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