Job Closed

This listing is no longer active.

Regulatory Submissions Manager

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

India

Posted

76 days ago

Salary

0

Seniority

Senior

Bachelor Degree6 yrs expEnglish

Job Description

Regulatory Submissions Manager

ICON plc

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA • Provide regulatory guidance and efforts to internal teams • Participate in agency interactions and regulatory submissions • Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines • Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Job Requirements

  • Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
  • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
  • Prior experience with various regulatory submissions, including CTA/IND/MAA
  • Ability to lead internal teams and carry out regulatory activities independently
  • Strong understanding of global regulatory requirements and guidelines

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Related Categories

Related Job Pages

More Compliance Jobs

Head of Compliance

The Better Money Company

We believe stablecoins are better money and will be the backbone of better payments. We see key structural problems hindering stablecoin adoption, and we’re going to fix them – starting with building a clearinghouse. We’re a small, scrappy team based in NYC, we’ve raised $10M from a16z Crypto and other excellent partners, and we’re going to bring better money to the world.

Compliance76 days ago

Role Description The next wave of stablecoin adoption is payments. We’re building a stablecoin clearinghouse to make stablecoins move like money, not a trading asset. We’re building for the long-term, and that means focusing on compliance from day one. Help us come build out and scale our program. - Build and manage our compliance program, including BSA/AML, KYC, and sanctions screening frameworks - Lead money transmitter license (MTL) applications at the state level - Develop, maintain, and operationalize compliance policies, procedures, and controls - Hire and build out the compliance team over time Qualifications - You’ve been the head of compliance or CCO of a licensed money transmitter or bank. - You’ve led preparation and filing of MTL applications across multiple states. - Strong working knowledge of BSA/AML, KYC/KYB, OFAC, and state money transmission regulations. - Familiarity with stablecoin, crypto, or digital asset regulatory landscape is a plus. - You are creative and a problem solver. You approach problems with solutions. Benefits - Competitive salary and equity - Comprehensive insurance (medical/dental/vision) - Unlimited vacation: Take time when you need it - Periodic off-sites Company Description We believe stablecoins are better money and will be the backbone of better payments. We see key structural problems hindering stablecoin adoption, and we’re going to fix them – starting with building a clearinghouse. We’re a small, scrappy team based in NYC, we’ve raised $10M from a16z Crypto and other excellent partners, and we’re going to bring better money to the world.

United States
$150K - $225K / year
Full TimeRemoteTeam 10,001+H1B Sponsor

Role Description The IT SOX Compliance – Senior Analyst is responsible for overseeing and coordinating IT-related Sarbanes-Oxley (SOX) compliance activities to ensure adherence to regulatory requirements and internal control standards. This role involves: - Supporting IT SOX testing - Developing and tracking management action plans for identified deficiencies - Providing status updates on remediation commitments - Ensuring the ongoing collection and documentation of process-related control evidence throughout the fiscal year The ideal candidate will have a strong background in IT compliance, with a minimum of 4-6 years of experience in IT SOX compliance or related fields. This is a Remote opportunity. Qualifications - Minimum of 4-6 years of experience in IT SOX compliance with a proven track record in coordinating SOX testing and remediation activities - Bachelor’s degree in Information Technology, Accounting, Finance, or a related field. Advanced degrees (e.g., MBA, MS in Information Systems) or certifications (e.g., CISA, CPA, or CRISC) are preferred - Strong understanding of IT general controls (ITGC), application controls, and SOX 404 requirements - Familiarity with frameworks such as COSO, COBIT, or NIST - Proficiency in GRC (Governance, Risk, and Compliance) tools and software (e.g., AuditBoard, Workiva, or similar) - Excellent project management and organizational skills with the ability to manage multiple priorities and deadlines - Strong analytical and problem-solving abilities to address control deficiencies effectively - Exceptional communication skills, both written and verbal, to interact with cross-functional teams and present to senior leadership - Experience conducting constructive conversations with IT control owners to identify & resolve control issues, promoting a culture of continuous improvement - Detail-oriented with a commitment to accuracy in evidence collection and documentation - Strong operational understanding of regulatory compliance requirements, particularly Sarbanes-Oxley, and their application to IT environments Requirements - Experience working with Big Four or other leading audit firms - Knowledge of IT systems, including platforms (e.g., SAP, Salesforce, Workday) and cloud-based environments - Prior experience in a publicly traded company with SOX compliance obligations Benefits - Safe, stable, reliable work environments - Medical, dental, and basic life and disability insurance benefits - 401k retirement plan - Paid time off - Annual bonus eligibility - A minimum of 7 holidays throughout the calendar year

United States
Full TimeRemoteTeam 201-500H1B No Sponsor

• Provides direction to all activities related to planning studies, environmental assessments and permit applications for the Mount Nansen Remediation Project. • Provides regulatory leadership for the Mount Nansen Remediation Project from planning through execution and completion. • Work collaboratively with technical teams and proactively identify opportunities to improve project environmental design aspects and streamline regulatory processes. • Develops an integrated project schedule including the critical path for the end-to-end tasks and activities necessary to successfully execute the project. • Interface and communicate with various levels of government, stakeholders and communities to advance permitting and WUL activities. • Represent MNRLP in regulatory and community meetings, workshops and events and oversee the preparation of presentation materials. • Keep abreast of existing and pending legislation and regulation changes which may impact the project. Coordinate and disseminate regulatory information within the JV. • Conducts senior reviews of technical deliverables and programs in area(s) of expertise. • Supports risk analysis with project management. • Monitor and promote system environmental health and worker safety compliance. • Completes other projects, reporting and tasks as assigned. • All other related duties as required.

Canada
$110K - $183K / year
Savan logo

CUI/CBI Regulatory Analyst

Savan

A Data & Information Management Consultancy

Compliance76 days ago
Full TimeRemoteTeam 51-200Since 2006H1B No Sponsor

Savan Group is seeking a CUI/CBI Regulatory Analyst to support a federal client in implementing and sustaining its Controlled Unclassified Information (CUI) and Confidential Business Information (CBI) programs. This role requires strong program support, policy analysis, coordination skills, and familiarity with federal information systems. The analyst will apply knowledge of federal information protection requirements, including those related to the handling, marking, dissemination, and safeguarding of CUI. The role focuses on translating regulatory and policy requirements into practical, actionable approaches. Responsibilities include supporting discovery and analysis efforts, reviewing system information, identifying applicable protection controls, and helping drive consistent adoption of CUI/CBI practices across the agency. This position also supports program execution by helping develop processes, engage stakeholders, and implement repeatable approaches that strengthen compliance with federal CUI and CBI requirements. Role Responsibilities: - Serve as a lead advisor on CBI policy requirements, ensuring alignment with federal mandates and agency priorities. - Analyze agency practices, systems, and gaps to inform CUI/CBI implementation strategies and continuous improvement efforts. - Coordinate and engage with cross-functional stakeholders to ensure consistency in CUI and CBI implementation activities. - Provide day-to-day program support, including implementation of updated regulations, policies, and guidance. - Develop and maintain standardized processes, workflows, and SOPs to support efficient program operations. - Create templates, guidance, and compliance documentation to support regulatory and procedural requirements. - Support system related requirements development for systems that store, process, or transmit CBI. - Develop briefings, memos, and decision support materials, and provide advisory support to senior leadership on program and regulatory matters. - Support the development of compliance tracking approaches and associated documentation. - Monitor federal CUI and information management policy updates and assess potential impacts on the program. Qualifications and Requirements: - Understanding of Executive Order 13556 and 32 CFR Part 2002. - Excellent analytical, writing, and client communication skills. - Experience managing stakeholders with competing priorities. - Understanding of records management principles and the data lifecycle. - Bachelor’s degree in business, public administration, public policy, library science, information systems, or a related field. - Demonstrated up to 4 years of experience supporting federal program implementation, policy and process development, or regulatory compliance initiatives. - Strong analytical abilities, with experience translating regulatory requirements into actionable guidance. - Understanding of records management principles and the data lifecycle. - Proficiency in Microsoft PowerPoint, Word, MS Teams, and SharePoint. - U.S. Citizenship required. Preferred Qualifications: - Master’s degree in Business, Public Policy, Library Science, or a related field. - Experience supporting a federal IT, information management, or records program in a program support or governance capacity. - Familiarity with enterprise-level information governance, compliance frameworks, or change management. - Experience supporting multi-stakeholder initiatives involving policy, process, and systems alignment. Work Location and Schedule: - Remote Schedule Application Process Submit your application to the link on this page. Applicants selected for interviews will be notified by email or phone. Compensation Savan believes in offering fair and competitive compensation to all employees. Our salary structures are based on industry standards, market conditions, and the specific demands of each role. Salary determination for potential new employees is influenced by a combination of factors, including years of experience, educational qualifications, specialized skills and expertise relevant to the job, complexity, and scope of the role's responsibilities, internal salary structures, as well as the geographic location of the job. Salary history will not be used in compensation decisions. EEO, including disability and veterans. Savan is an Equal Opportunity Employer and is committed to a workplace free of discrimination. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), gender identity, sexual orientation, national origin, age (40 or older), marital status, disability, genetic information, status as a protected veteran, or any other applicable legally protected characteristics. If you are an individual with a disability and would like to request reasonable accommodation for the employment process, please email your request to humanresources@savangroup.com. For more information about our company, please visit our website at www.savangroup.com.

United States