Strategic Regulatory and Quality Expert

Serve as a senior enterprise-level expert who integrates regulatory strategy, product quality, CMC science, and manufacturing risk across the development and lifecycle of biologics and other complex modalities. The role provides independent, high-impact advice on global regulatory pathways, submission and inspection strategy, quality and compliance risks, and technically defensible decision-making. Working through influence rather than formal authority, the expert partners with Regulatory Affairs, Analytical Sciences, Quality Control, Quality Assurance, Process Development, Manufacturing, Project Management, Business Development, and client teams to strengthen program outcomes, regulatory readiness, and organizational capability.

• Define and advise on integrated CMC regulatory and quality strategies from pre-IND development through registration, commercialization, post-approval changes, and lifecycle management, with particular emphasis on biologics and complex products.
• Provide senior-level interpretation of global regulatory requirements and health authority expectations, translating them into pragmatic development, control strategy, validation, manufacturing, and filing plans.
• Conduct independent, risk-based reviews of CMC strategies, Module 3 content, briefing packages, responses to information requests or deficiencies, comparability packages, post-approval supplements, and other critical regulatory deliverables.
• Advise project and functional leaders on complex or ambiguous regulatory and quality issues; frame options, risks, evidence gaps, decision criteria, and recommended paths forward for leadership and client decisions.
• Support preparation for health authority interactions, including meeting strategy, key messages, anticipated questions, technical rehearsal, and follow-up commitments. Participate as a senior subject-matter expert when appropriate.
• Integrate product, process, analytical, facility, quality-system, and inspection information to assess manufacturing and approval readiness. Guide remediation and escalation of material regulatory or compliance risks.
• Provide strategic guidance for pre-approval inspection and general inspection readiness, including review of evidence packages, risk narratives, data traceability, cross-functional consistency, and response strategy.
• Serve as an expert reviewer and thought partner for high-priority, novel, or challenged programs, including due diligence, governance reviews, regulatory risk assessments, and critical client engagements.
• Build organizational capability through mentoring, technical forums, case-based training, and coaching of regulatory, quality, analytical, manufacturing, and CMC leaders. Foster empowered decision-making rather than acting as the default problem solver.
• Monitor emerging regulations, regulatory precedents, enforcement trends, and scientific developments; assess relevance to the portfolio and recommend timely changes to strategy, systems, and service offerings.
• Represent the company externally, as appropriate, in client discussions, scientific or regulatory forums, and industry engagement, while protecting confidential information and maintaining professional integrity.

• Enterprise and portfolio impact, with assignments focused on the most complex, novel, high-risk, or strategically important programs.
• Professional-track leadership: no formal people-management requirement, but expected to lead cross-functional teams, influence senior stakeholders, and shape enterprise standards.
• Decision authority is advisory and governance-based; the role escalates material risks and makes clear recommendations while accountable functions retain formal approval authority.
• May lead time-bound expert task forces, independent reviews, inspection-readiness work streams, or strategic client engagements.

• Ph.D. or equivalent advanced degree in pharmaceutical sciences, analytical chemistry, biochemistry, biotechnology, chemical/biochemical engineering, regulatory science, or a related field. An M.S. with exceptional depth and directly relevant leadership experience may be considered.
• Typically 15+ years of progressively responsible experience in CMC regulatory affairs, pharmaceutical quality, biologics development, manufacturing, analytical sciences, or a closely related field, with substantial experience at senior expert or leadership level.
• Demonstrated responsibility for major regulatory submissions and…