Job Closed

This listing is no longer active.

Sabin Vaccine Institute logo
Sabin Vaccine Institute

We are a global health non-profit on a mission to make vaccines more accessible, enable innovation & expand immunization

Director, CMC Regulatory

ComplianceComplianceFull TimeRemoteLeadTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

71 days ago

Salary

$180K - $205K / year

Seniority

Lead

Bachelor Degree12 yrs expEnglish

Job Description

Director, CMC Regulatory

Sabin Vaccine Institute

• Provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development • Lead planning, development, and delivery of high-quality CMC content and documentation • Collaborate with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders • Author and critically review CMC sections of U.S. FDA submissions and lifecycle updates • Drive CMC regulatory support for global development and access • Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies • Maintain a strong global regulatory intelligence posture • Support engagement and negotiation with regulators to resolve key CMC issues

Job Requirements

  • Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required, advanced degree highly desired
  • 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development
  • Proven track record in leading Regulatory CMC activities for regulatory filings in both pre- and post-approval settings
  • Experience in regulatory oversight of validation lifecycle activities, including process performance qualification (PPQ), continued process verification (CPV), and inclusion of validation data and information in marketing applications
  • Thorough knowledge of biologics development, cGMPs, regulatory submissions, FDA regulations, ICH guidance, and industry standards
  • Experience preparing regulatory submissions and briefing packages for regulatory meetings
  • Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus
  • Excellent interpersonal, active listening, and influencing skills
  • Ability to manage complex tasks, prioritize competing objectives, and work well under pressure, maintaining clear purpose and attention to detail
  • Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat.

Benefits

  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Flexible spending accounts
  • Flexible vacation leave
  • Sick leave
  • Short-term disability options
  • Long-term disability options
  • 10 federal holidays
  • End of the year winter break
  • Employer matching 401(k) plan

Related Categories

Related Job Pages

More Compliance Jobs

Global Regulatory Writing & Consulting (GLOBAL) logo

Medical Device Regulatory Affairs – Clinical Evaluation Manager

Global Regulatory Writing & Consulting (GLOBAL)

GLOBAL specializes in complex biologics, drugs, medical devices, IVDs, & combination products

Compliance71 days ago
Full TimeRemoteTeam 51-200H1B No Sponsor

• Responsible for the end-to-end planning, execution, and delivery of medical device regulatory writing projects across global regulatory frameworks. • Focus on EU MDR Clinical Evaluation (including CERs). • Support premarket regulatory submissions in either the United States (e.g., 510(k), De Novo, PMA) and/or EU MDR Technical Documentation. • Oversee complex documentation programs (e.g., CERs, PMCF, SSCPs, Technical Documentation, and premarket submission dossiers) and/or manage large client portfolios across multiple products and regulatory jurisdictions. • Provide leadership and operational oversight to a team of Medtech Medical Writers, ensuring high-quality, compliant, and timely deliverables. • Directing, delegating, and reviewing work; establishing clear project expectations; maintaining accountability for performance against timelines, budgets, and quality standards. • Interpret and operationalize regulatory requirements into executable project plans and writing strategies. • Drive continuous improvement of templates, processes, and workflows to enhance efficiency, scalability, and quality. • Contribute to business development activities, including marketing, proposal development, scoping, and client onboarding.

United States
$125K - $150K / year
Job Closed
Way to Win logo

Senior Compliance Manager

Way to Win

Upending politics as usual

Compliance71 days ago
Full TimeRemoteTeam 11-50Since 2017H1B No Sponsor

• Support advocacy, political, and programmatic operations across the organization’s multi-entity structure. • Work closely with the Executive Vice President/Chief Operating Officer (EVP/COO) and collaborate across program, communications, political, and operations teams to ensure compliance with federal, state, and local regulations. • Oversee lobbying compliance, independent expenditure reporting, regulatory registrations, and internal compliance review processes. • Identify and mitigate compliance risks associated with advocacy campaigns, messaging, vendor contracts, and program activities. • Manage charitable solicitation registrations, business registrations, and related regulatory filings.

United States
$110K - $120K / year
Job Closed
Full TimeRemoteTeam 1,001-5,000H1B Sponsor

• Leads the development and maintenance of contract language and materials to support projects/initiatives for Florida Blue's ASO business. • Reviews and evaluates business requirements to determine contract material impacts and identify any issues. • Works closely with ASO business leads and other key business stakeholders to ensure business needs are clearly defined. • Works with Sales, Legal, Segment and ASO Partner Platform stakeholders to translate business requirements into legally-compliant ASO contract language. • Interprets and ensures compliance with all legislative, regulatory, and BCBSA Inter-Plan Program requirements. • Creates and memorializes finalized forms and redlines. • Leads or supports auditing and/or system testing of contract materials. • Utilizes project management processes to ensure project deliverables are delivered on time. • Communicates and collaborates effectively with cross-enterprise business areas to ensure all compliance, regulatory and project deadlines are met. • Supports the organization, maintenance and data integrity of contract databases and libraries. • Identifies any potential issues or discrepancies and works to implement solutions. • Researches and provides consultation on requests from internal business partners. • Timely retrieval and dissemination of contract language and materials to support business needs.

United States
$77.6K - $126.1K / year
Job Closed
OKX logo

Head of Compliance, MLRO

OKX

Discover the future of investing, built on top of the world’s most trusted crypto trading app, and web3 platform.

Compliance71 days ago
Full TimeRemoteTeam 1,001-5,000Since 2017H1B No Sponsor

• Lead the preparation and submission of the AFSA licence application including drafting compliance-related sections of the application pack • Serve as the primary point of contact with the AFSA and other relevant Kazakhstani regulatory bodies throughout the licensing process and on an ongoing basis • Ensure the organisation meets all AIFC governance requirements, including fit and proper obligations for Approved and Designated Persons • Monitor and interpret regulatory developments under the Law of the Republic of Kazakhstan "On Digital Assets" (No. 193-VII), AIFC Acts, and associated AFSA rules, and advise the Board accordingly • Design, implement, and maintain a comprehensive compliance framework aligned with AIFC requirements, FATF recommendations, and international best practice for virtual asset service providers (VASPs) • Develop, review, and update all internal policies and procedures covering AML/CFT, KYC, customer due diligence (CDD), enhanced due diligence (EDD), transaction monitoring, sanctions screening, data protection, cybersecurity compliance, and safeguarding of client assets • Establish and oversee the compliance monitoring programme, including periodic testing, gap analysis, and reporting to senior management and the Board • Prepare and present regular compliance reports to the Board and relevant committees, including on regulatory changes, compliance breaches, and remediation progress • Act as the designated MLRO, with full statutory responsibility for overseeing the organisation's AML/CFT framework in accordance with Kazakhstan Law and AIFC AML rules • Receive, review, and assess all internal Suspicious Activity Reports (SARs) from staff, and make informed decisions on whether to file external disclosures with Kazakhstan's Financial Intelligence Unit (FIU) and other competent authorities • Oversee and continuously improve the transaction monitoring programme, with support from global compliance and product functions • Ensure robust sanctions screening against all applicable lists, including OFAC, UK OFSI, UN, EU, and domestic Kazakhstan sanctions designations • Oversee customer risk scoring, risk-based KYC/CDD processes, and enhanced due diligence for high-risk customers, politically exposed persons (PEPs), and customers from high-risk jurisdictions • Act as a key member of the senior leadership team, providing compliance input on new products, services, partnerships, and business initiatives • Champion a strong compliance culture across the organisation through training, communications, and leadership by example • Design and deliver AML/CFT and compliance training programmes for all staff, ensuring completion records are maintained • Ensure that the organisation's compliance obligations are adequately resourced, and advise the Board on staffing, systems, and budget requirements • Establish and maintain a compliance manual, risk register and oversee the escalation and resolution of compliance incidents and breaches • Prepare and submit all required regulatory reports and notifications to AFSA, the Financial Intelligence Unit, and other authorities within stipulated deadlines • Ensure that all compliance records, SAR documentation, KYC files, and transaction monitoring records are maintained in accordance with applicable retention requirements • Support and facilitate any AFSA inspections, supervisory visits, or regulatory examinations.

Kazakhstan