Lumanity logo
Lumanity

Incisive Thinking, Decisive Action

Vice President, Regulatory Strategy

ComplianceComplianceFull TimeRemoteLeadTeam 1,001-5,000Since 2020H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

30 days ago

Salary

0

Seniority

Lead

Postgraduate Degree20 yrs expEnglish

Job Description

Vice President, Regulatory Strategy

Lumanity

• Acts as trusted strategic partner to pharmaceutical and biotech C-suite executives and other functional heads, influencing enterprise-wide regulatory strategies that extend across multiple development programs and corporate initiatives • Provides authoritative regulatory guidance on complex, multi-indication development programs, including novel modalities (cell/gene therapy, biologics, advanced therapeutics) • Partners with other Lumanity practices to deliver integrated solutions addressing interconnected regulatory, clinical, and quality challenges • Partners with SVP & Practice Lead to translate regulatory landscape changes (AI/digital submissions, global harmonization, policy evolution) into practice growth opportunities and competitive differentiation • Develops regulatory points of view that influence industry standards, shapes regulatory policy dialogue, and positions Lumanity as the authoritative voice in regulatory strategy consulting • Evolves consulting methodologies and develops new service offerings to address emerging regulatory challenges and client needs • Proactively supports the Clinical & Regulatory P&L, in collaboration with the SVP and Practice Lead, achieving annual revenue targets while maintaining target profitability margins • Dives personal and team BD performance, leading pursuit strategies for complex, high-value regulatory engagements while mentoring BD capability across the practice • Sets and reinforces delivery quality standards across regulatory team, ensuring consistency in regulatory strategy outputs while balancing profitability with client value • Shapes regulatory talent strategy through succession planning, mentorship of senior regulatory leaders, and development of next-generation regulatory capabilities • Champions collaboration and knowledge sharing across markets, accelerating reuse of regulatory frameworks and best practices • Represents Lumanity at senior industry forums and regulatory conferences building external credibility and market presence • Monitors regulatory competitive landscape and translates insights into practice positioning and service evolution

Job Requirements

  • Minimum 20+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory leadership roles
  • Direct experience leading regulatory strategies for development programs throughout all stages and across different therapeutic areas and product types
  • Demonstrated success managing regulatory practices or teams
  • Proven ability to serve as trusted advisor to pharmaceutical/biotech VP-level and C-suite executives
  • Deep expertise across pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies
  • Extensive experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions
  • International regulatory experience across major markets (EMA, Health Canada, PMDA) with understanding of global regulatory harmonization
  • Deep regulatory expertise in 2+ major therapeutic areas (oncology, CNS, rare disease, immunology, etc.)
  • Experience across multiple product types including small molecules, biologics, cell/gene therapies, and combination products
  • PhD, MPH, or MS in life sciences, regulatory affairs, or related field
  • MBA, RAC certification, or equivalent business/regulatory qualifications
  • Proven track record achieving annual revenue targets with demonstrated budget management experience
  • Success in opening new markets or service lines within regulatory consulting
  • Published regulatory thought leadership, speaking engagements, and recognition as regulatory industry authority

Benefits

  • Competitive salary plus bonus scheme
  • Medical, dental, and vision insurance options
  • 401(k) plan with employer match
  • Flexible PTO
  • Flexible spending accounts for health and dependent care
  • Health savings account option with employer contribution
  • Employee Assistance Program
  • Paid short-term and long-term disability coverage and much more

Related Categories

Related Job Pages

More Compliance Jobs

Benevity logo

GRC Analyst

Benevity

The way the world does good.

Compliance30 days ago
Full TimeRemoteTeam 501-1,000H1B No Sponsor

• Assist in maintaining and rolling out security and privacy policies, standards, and control frameworks aligned to ISO 27001, SOC 2, NIST, PCI DSS, GDPR, PIPEDA, FINTRAC, and other global regulations • Support policy exception management, attestation processes, and identify opportunities for process improvement • Assist with enterprise risk assessments, including vendor and process-level reviews • Support maintenance of the risk register, track remediation activities, and assist with risk treatment planning • Contribute to Benevity’s Third-Party Risk Management (TPRM) program, including vendor onboarding assessments, ongoing monitoring, and remediation tracking • Support audit readiness and response efforts for ISO 27001, SOC 2, PCI DSS, GDPR, PIPEDA, FINTRAC, and other frameworks • Assist with evidence gathering, control validation, and auditor engagement • Leverage GRC platforms to support audit, privacy, and compliance workflows • Support the sales process by responding to client inquiries related to security, privacy, and compliance • Complete customer security questionnaires, RFPs, and third-party risk management (TPRM) requests • Partner with sales and client success teams to provide timely, accurate responses that build client trust • Support privacy-related initiatives across jurisdictions (GDPR, PIPEDA, CCPA/CPRA, and others) • Collaborate with legal and data governance teams to help ensure compliance with data protection and financial crime regulations • Assist with FINTRAC-related compliance requirements, including reporting and risk assessments related to AML/ATF obligations • Monitor regulatory changes (privacy, AML, financial crime) and help align internal processes accordingly • Partner with business and technical teams to support the embedding of risk and compliance into projects and initiatives • Assist in delivering reporting and insights (dashboards, risk metrics, summaries) for leadership • Contribute to Benevity’s Security Awareness & Training program, including awareness campaigns, training modules, and phishing simulations • Contribute to training, documentation, and awareness activities that strengthen Benevity’s security, privacy, and compliance culture

Canada
Job Closed
Owlet Baby Care logo

IT Compliance Analyst

Owlet Baby Care

Founded in 2013, Owlet Baby Care was established to provide products that keep babies safe and provide parents with the peace of mind to "find more joy in the parenthood journey."

Compliance30 days ago

- Execute and document ITGC control testing across Owlet's key systems and platforms. - Collect, organize, and maintain control evidence in accordance with audit requirements. - Track control deficiencies and remediation items to closure under IT Director oversight. - Support SOX readiness activities and auditor walkthroughs, including preparing materials and responding to auditor requests. - Coordinate evidence collection and auditor access for internal audit, external financial audit, and SOC report engagements. - Maintain the audit evidence repository and ensure documentation is current, organized, and audit-ready throughout the year. - Serve as a reliable point of contact for auditor information requests, escalating to the IT Director as needed. - Maintain Owlet's IT policy library: version control, review tracking, and attestation coordination. - Support annual policy review cycles by flagging outdated content and drafting proposed updates for IT Director review and approval. - Assist with communicating policy updates and awareness initiatives across the organization. - Maintain the IT compliance risk register: keeping entries current, tracking status, and flagging items that need IT Director attention. - Support IT change management processes to preserve audit trail integrity and separation of duties controls. - Assist with the IT component of third-party vendor compliance documentation as directed.

United States
Pearce Services logo

Director, Compliance

Pearce Services

Providing mission-critical infrastructure solutions to create a more connected and sustainable future.

Compliance30 days ago
Full TimeRemoteTeam 1,001-5,000H1B No Sponsor

• Lead and manage compliance with NERC, FERC, and other federal electric regulatory requirements, as well as state and ISO/RTO requirements, with a focus on NERC 693 requirements and EIA submissions. • Oversee compliance matters for NERC-registered entities and assets within X-ELIO NA. • Prepare and submit timely and accurate NERC, FERC, ERCOT, PUCT, and EIA filings. • Lead the preparation for audits, self-certifications, spot checks, data submittals, and self-reports. • Develop, implement, and maintain compliance procedures, internal controls, and preventive measures. • Maintain documentation and evidence supporting compliance with all applicable requirements. • Monitor and analyze regulatory developments at NERC, ERCOT, ISO/RTOs, and other authorities, ensuring timely adaptation to new or changing rules. • Collaborate with internal stakeholders to assess the impact of regulatory changes and coordinate compliance strategies. • Participate in regulatory and reliability forums, representing the company in outreach activities. • Assist in coordinating and delivering compliance training to internal contributors and stakeholders. • Partner with internal groups and SMEs to resolve compliance issues and track corrective actions.

Texas
$50 - $60 / hour
Job Closed
Oxfam America logo

Engagement & Volunteer Advisor

Oxfam America

We’re fighting global inequality to end poverty and injustice, so that everyone can thrive, not just survive. Join us.

Compliance30 days ago
Full TimeRemoteTeam 201-500Since 1942H1B Sponsor

Role Description The Engagement & Volunteer Advisor supports the implementation of Oxfam America’s Brand & Engagement strategy by helping deliver volunteer-powered engagement experiences and brand activation initiatives. This role operates under the leadership of the Senior Manager, Brand & Engagement, who sets the strategic direction for flagship programs including all cultural outreach, the Oxfam Hunger Banquet, and many broader brand activation initiatives. This position plays a key role in delivering a consistent and high-quality volunteer experience across brand initiatives and connecting participation opportunities to broader engagement and organizing pathways. The Advisor plays a key role in translating strategic brand and engagement priorities into actionable volunteer experiences that can scale across markets. This role contributes to activation efforts nationally, with a focus for the next few years on priority markets including Los Angeles, Austin, Philadelphia, Chicago, and the San Francisco Bay Area. Primary Responsibilities - Oxfam Hunger Banquet Program Delivery & Experience - Support the implementation and continuous improvement of Oxfam America’s Hunger Banquet program. - Maintain and strategically update Oxfam Hunger Banquet toolkits, training materials, facilitation guides, and brand assets. - Serve as primary point of contact for Oxfam Hunger Banquet hosts and facilitators. - Track and analyze participation, engagement, and feedback to inform program improvements and scalability. - Brand Activation & Community Engagement - Support the execution and delivery of volunteer-integrated brand and community activation initiatives. - Ensure brand activations include clear volunteer roles, timelines, communications, and follow-up steps. - Partner with Organizing, Events, Music Outreach, and Strategic Partnerships colleagues. - Contribute to the adaptation and scaling of activation models across priority markets. - Volunteer Experience & Communications - Support the delivery of clear, timely, and engaging communications to volunteers. - Facilitate volunteer onboarding, scheduling, and readiness for in-person and virtual activation. - Help ensure volunteers receive timely information, clear expectations, and follow-up communications. - Contribute to pathways that move volunteers from initial participation into deeper engagement and organizing opportunities. - Cross-Team Collaboration & Supporter Experience - Work closely with the Engagement & Organizing Advisor and team to align volunteer roles and messaging. - Support data tracking, reporting, and CRM hygiene related to volunteer participation. - Share feedback from volunteers to inform learning and program improvement. - Contribute to a positive, inclusive, and values-aligned volunteer experience. - Learning & Continuous Improvement - Assist with tracking engagement metrics related to Hunger Banquets and other brand activations. - Support collection of volunteer and participant feedback. - Contribute to iterative improvements to tools, trainings, and activation workflows. Qualifications - Bachelor’s degree or equivalent combination of work experience, education, and training. - 3 - 5 years of experience in volunteer coordination, community engagement, events, organizing, or brand activation. - 2+ years project management experience required. - Experience running and/or systematizing volunteer-led or community-based programs. - Experience delivering and implementing brand and engagement activations. - Proficiency in digital tools for engagement and communication. - Excellent interpersonal, writing, and facilitation skills. - Strong organizational skills with ability to manage multiple projects simultaneously. - Ability to represent Oxfam in a variety of settings and with diverse audiences. - Good judgment, initiative, and ability to anticipate problems. - Ability to work independently and as part of a cross-functional remote team. - Commitment to equity, inclusion, and social justice values. Preferred Qualifications - Experience organizing experiential, immersive, educational, or facilitation-based programs. - Familiarity with digital communications, CRM systems, and volunteer engagement tools. - Experience in nonprofit or advocacy settings. - Multilingual skills a plus. Position Expectations - Will stay abreast of professional standards, trends, and issues affecting this set of responsibilities. - Will work effectively and collaboratively in support of building a team-based, problem-solving work culture. - Will have a fundamental understanding of gender justice and diversity within key areas of responsibility. - Will have a commitment to and be accountable for activities contributing towards a safe and accountable workplace environment. - Helps advance brand and engagement priorities through grassroots mobilization, volunteer leadership development, and strategic community activation. - Willing to travel domestically; occasional evening and weekend work is required. Additional Information - Oxfam America is a Gender Just organization and an equal opportunity employer. - We welcome all qualified applicants and do not discriminate on the basis of race, color, gender, national origin, age, religion, creed, disability, veteran status, sexual orientation, gender identity, or gender expression. - We provide reasonable accommodations to applicants with disabilities upon request.

United States
$75K - $80K / year