SVP/Global Head, Regulatory Affairs
Description
Our client, a novel, rapidly-growing clinical-stage biotechnology company, has retained us to identify a Senior Vice President, Regulatory Affairs to lead its growing global regulatory organization.
This is a highly visible senior leadership role at a pivotal stage of the company’s evolution, with multiple programs advancing through clinical development toward late-stage development and potential registration. The SVP will serve as the company’s senior-most regulatory leader, partnering closely with the executive team, Board and cross-functional leadership while representing the organization with the FDA and other global health authorities.
The position offers the opportunity to shape the regulatory strategy, infrastructure and team required to advance a novel class of medicines from clinical development through potential approval and commercialization.
Location
Boston Area
Features
ATTRACTIVE FEATURES:
- Executive-level visibility and influence – Serve as the company’s senior-most regulatory voice, reporting to the CMO, advising executive leadership and the Board on strategy, risk and key development decisions.
- High-impact biotech environment – Join an established clinical-stage company with a differentiated pipeline, significant partnerships, and an opportunity to establish regulatory precedent within an emerging field.
- Lead toward potential first-in-class approvals – Guide multiple clinical programs toward registration within an innovative and emerging therapeutic modality.
- Build and shape the regulatory organization – Develop the capabilities, infrastructure and team needed as the company evolves toward a registration-stage and commercial organization.
- Broad global regulatory ownership – Lead strategy across development programs, major health-authority interactions, submissions and international expansion.
Responsibilities
KEY RESPONSIBILITIES:
- Define and drive global regulatory strategy across the company’s pipeline from clinical development through potential marketing applications.
- Serve as the primary regulatory interface with the FDA and other global health authorities, leading critical meetings and formal regulatory interactions.
- Provide strategic leadership for INDs, CTAs, briefing packages and eventual NDA/BLA and international marketing applications.
- Build, develop and lead a scalable Regulatory Affairs organization encompassing regulatory strategy and related regulatory capabilities.
- Partner closely with Clinical Development, Biometrics, CMC/Manufacturing, Quality, Pharmacovigilance, Legal and Commercial leadership to align regulatory strategy with development plans and business objectives.
- Lead regulatory strategy and governance for partnered development programs, working effectively with large pharmaceutical collaborators.
- Anticipate evolving regulatory requirements for novel therapeutic modalities and advise senior leadership on regulatory opportunities, risks and precedent-setting issues.
- Represent the company externally with health authorities and, as appropriate, industry and regulatory policy organizations.
Qualifications / Requirements
IDEAL BACKGROUND:
- 15+ years of progressive Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry, including significant leadership responsibility.
- Demonstrated success leading regulatory strategy from IND through late-stage development and registration, with NDA/BLA or MAA submission experience required.
- Direct, senior-level experience interacting with the FDA and other major global health authorities.
- Meaningful therapeutic-area experience in immunology, inflammation or a related specialty area.
- Experience with novel or first-in-class therapeutic modalities strongly valued.
- Experience supporting partnered programs, licensing/co-development relationships or regulatory governance with pharmaceutical collaborators is a plus.
- Proven ability to build, scale and lead high-performing regulatory teams within a growing organization.
- Strong executive presence and communication skills, with the ability to advise C-suite leadership and Boards on complex regulatory strategy and risk.
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