Strategic Regulatory and Quality Expert

WuXi Biologics; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

WuXi Biologics seeks a senior enterprise-level expert to integrate regulatory strategy, product quality, CMC science, and manufacturing risk across development and lifecycle of biologics and complex modalities.

The role provides independent, high-impact advice on global regulatory pathways, inspection strategy, and risk-based decision-making, partnering across Regulatory Affairs, Analytical Sciences, Quality, Process Development, Manufacturing, and client teams.

Qualifications

• Ph.D. or equivalent in pharmaceutical sciences or related field; M.S. with depth and leadership experience may be considered.
• Typically 15+ years in CMC regulatory affairs, pharmaceutical quality, biologics development, or related fields at senior or leadership level.
• Experience managing major regulatory submissions and health authority interactions across lifecycle stages.
• Strong working knowledge of ICH, GMP, quality systems, validation, comparability, control strategy, and inspection readiness.
• Broad technical understanding across drug substance, drug product, analytics, manufacturing, and facilities.
• Experience with biologics is required; breadth across antibodies, multispecifics, ADCs, biosimilars, and advanced modalities preferred.
• Proven ability to resolve cross-functional issues using scientific judgment and clear documentation.

Responsibilities

• Define and advise on integrated CMC regulatory and quality strategies from pre-IND through registration and lifecycle management.
• Provide senior interpretation of global regulatory requirements and translate them into pragmatic plans.
• Conduct independent, risk-based reviews of CMC strategies, Module 3 content, and critical regulatory deliverables.
• Advise leaders on complex regulatory and quality issues; present options, risks, and recommended paths.
• Support health authority interactions including meeting strategy, key messages, and follow-up commitments.
• Integrate product, process, analytical, facility, quality systems, and inspection data to assess readiness.
• Provide guidance for pre-approval inspections and inspection readiness activities.
• Serve as expert reviewer for high-priority programs, including due diligence and governance reviews.
• Mentor and coach regulatory, quality, analytical, manufacturing, and CMC leaders to raise standards.
• Monitor emerging regulations and industry trends; recommend timely strategy updates.
• Represent the company externally in client discussions and regulatory forums while protecting confidential data.

Skills

Regulatory strategy

Quality assurance

CMC science

Regulatory affairs leadership

Cross-functional collaboration

Risk-based decision making

Executive communication

Influence without authority

Biologics development

Inspection readiness

Education

Ph.D. in pharmaceutical sciences or related field

M.S. with relevant leadership experience

Job description

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.

Key Responsibilities

• 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.

Role Scope and Operating Model

• 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 workstreams, or strategic client engagements.

Education and Experience

• 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 health authority interactions across development, approval, and/or post-approval stages. Direct experience within a major health authority is highly valued but not required.
• Strong working knowledge of global CMC and quality expectations, including ICH principles, GMP, pharmaceutical quality systems, validation, comparability, control strategy, lifecycle management, and inspection readiness.
• Broad technical understanding across drug substance, drug product, analytical control, manufacturing processes, facilities/equipment, materials, packaging, stability, and laboratory controls.
• Experience with biologics is required; breadth across monoclonal antibodies, multispecifics, ADCs, biosimilars, enzymes, peptides, nucleic-acid or other advanced modalities is preferred.
• Proven ability to resolve complex, cross-functional issues using scientific judgment, risk-based reasoning, and clear documentation.

Core Competencies

• Enterprise strategic thinking: connects regulatory, quality, technical, operational, client, and business implications.
• Scientific and regulatory judgment: distinguishes critical evidence from lower-value detail and forms defensible positions under uncertainty.
• Influence without authority: aligns senior stakeholders, constructively challenges assumptions, and drives decisions across functions and geographies.
• Executive communication: communicates complex topics with clarity, concision, and appropriate calibration for executives, clients, regulators, and technical teams.
• Independent leadership: initiates work, defines the problem, sets the review approach, and delivers actionable recommendations with limited direction.
• Coaching and capability building: develops others, creates reusable knowledge, and raises organizational standards beyond individual program delivery.
• Integrity and quality mindset: demonstrates sound judgment, transparency, respect for data, and commitment to patient and product quality.
• Fluent English communication is required; additional language capability and experience working across cultures are advantageous.

This is a job open to Location of China or US.