549 Vp Quality jobs in Trenton,NJ

AVP Underwriting Manager, or VP Senior Underwriting Manager, Construction Casualty

Zurich Insurance Company

Philadelphia, PA 19019

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Vice President, Global Regulatory Affairs, Team Lead, Strategy

Genmab

Plainsboro, NJ 08536

~ 23 min OnsiteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

Advanced scientific degree required; PhD in a bioscience discipline (e.g., molecular biology, pharmacology, immunology, biochemistry, or related life sciences) or MD strongly preferred.
Minimum of 15+ years of progressive experience in Global Regulatory Affairs within the biotech or pharmaceutical industry, with at least 8–10 years in roles of increasing leadership responsibility.
Demonstrated track record of successful global regulatory submissions (IND/CTA, BLA/NDA/MAA, supplements, and life-cycle management) across major health authorities including FDA, EMA, PMDA, and Health Canada.
Extensive experience leading and interacting with health authorities, including successful execution of Type A/B/C meetings, Scientific Advice, End-of-Phase meetings, Pre-BLA/NDA meetings, and Advisory Committee preparations.
Significant experience in oncology, immunology, or other complex therapeutic areas (biologics, antibody-drug conjugates, bispecifics, or novel modalities preferred).
Deep expertise across the full product lifecycle — from early development through late-stage clinical, registration, launch, and post-marketing.
Proven experience leading regulatory strategy for partnered or co-developed programs, including negotiation with collaboration partners.
Demonstrated success building, leading, and scaling high-performing global regulatory teams across multiple geographies.
Experience representing Regulatory Affairs at the executive level Governance Committees as required.
Comprehensive knowledge of global regulatory frameworks, including FDA (21 CFR), EMA (EU CTR, EU MDR where applicable), ICH guidelines, and emerging markets regulations.
Expertise in expedited regulatory pathways (Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval, PRIME, Orphan Drug Designation).
Strong understanding of CMC regulatory requirements, nonclinical and clinical regulatory expectations, pharmacovigilance, labeling, advertising/promotion, and post-marketing commitments.
Working knowledge of companion diagnostics (CDx) co-development and combination product regulations, where relevant.
Familiarity with regulatory information management systems, eCTD publishing, and digital submission platforms.
Ability to interpret emerging regulatory guidance, policy, and legislation and translate implications into actionable strategy.
Strategic thinker with the ability to translate regulatory science into actionable commercial and development strategy.
Exceptional executive presence and communication skills; able to influence and align stakeholders at all levels, from technical teams to C-suite and Board.
Demonstrated ability to navigate complex, matrixed, global organizations and drive alignment across R&D;, Clinical, CMC, Commercial, Legal, and Medical Affairs.
Strong decision-making skills under uncertainty; comfortable balancing scientific rigor, regulatory risk, and business priorities.
Inspirational people leader with a strong track record of coaching, mentoring, and developing talent.
Cultural awareness and experience working across geographies, particularly across US, EU, and Asia-Pacific regions.
High integrity, resilience, and the ability to thrive in a fast-paced, science-driven biotech environment.
Collaborative mindset with a bias for action and continuous improvement.
This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.
Domestic and international travel expected (approximately 10–20%) for health authority meetings, site visits, conferences, and team/partner engagements.

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Vice President, Program and Transaction Management

BAYADA Home Health Care

Pennsauken, NJ 08110

$195,000-$240,000/yr

RemoteHealth InsurancePaid Time OffRetirement Benefit

Four (4) year college degree.
Ten (10) or more years of experience with significant large-scale portfolio and enterprise project management with a broad and deep understanding of the healthcare industry.
Ten (10) years of relevant business experience leading the integration of new companies and/or joint ventures.
Proven experience leading direct reports and overseeing a multi-layered team structure.
Strong knowledge of project management methodologies, tools, and best practices.
Exceptional communication and interpersonal skills, with the ability to influence without authority.
Proficiency in building and maintaining effective relationships with internal and external stakeholders.
Possess very strong problem-solving ability, leadership skills, motivation skills, and ability to foster interpersonal relationships.
Ability to solve practical problems and deal with a variety of concrete variables in situations where some standardization exists.
Demonstrated track record of goal achievement, strong interpersonal skills, enterprise strategic thinking, and operational integration excellence.
Experience working directly with executive leadership teams and Board members.
Demonstrated experience leading enterprise-level transformation initiatives.
Acceptable pre-employment assessment results.
Ability to read, write and effectively communicate in English.

SmartExplore AI is experimental.