Vice President, Regulatory Affairs

ComplianceComplianceFull TimeRemoteLeadTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Virginia

Posted

7 days ago

Salary

$200K - $275K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglish

Job Description

Vice President, Regulatory Affairs

Contraline

• Develop and execute innovative regulatory strategies that maximize development efficiency and increase probability of approval. • Serve as the primary regulatory contact with FDA for Contraline and other health authorities worldwide. • Lead all regulatory aspects of product development from preclinical stages through commercialization. • Provide strategic input when required into corporate planning, fundraising activities, business development transactions, and investor communications. • Participate in nonpromotional and promotional review as the Regulatory Affairs representative. • Build and scale the regulatory affairs function as the organization grows. • Lead preparation for regulatory agency meetings including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA interactions. • Oversee preparation and submission of INDs, NDAs, BLAs, amendments, and global regulatory applications. • Provide regulatory leadership for drug-drug combination products and drug-device combination products. • Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners. • Evaluate emerging regulatory risks and opportunities and provide proactive mitigation strategies. • Support diligence activities related to partnerships, licensing opportunities, and acquisitions.

Job Requirements

  • Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant discipline and/or Regulatory Affairs Certification (RAC)
  • Minimum 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology companies
  • Significant experience leading FDA interactions and major regulatory submissions including experience with 505(b)(2) submissions
  • Demonstrated success obtaining IND clearances and advancing development programs through key regulatory milestones
  • Experience developing regulatory strategies for innovative therapeutic products.
  • Strong understanding of clinical development, CMC, nonclinical development, and commercialization requirements.
  • Proven ability to operate effectively in entrepreneurial, resource-constrained environments.

Benefits

  • Applicants must be authorized to work in the United States
  • Dedicated to building a diverse, inclusive and authentic workplace

Related Categories

Related Job Pages

More Compliance Jobs

Associate - Affordable Housing

JBA International

For over 25 years, leading global information technology services company JBA International has been providing premier software development, consulting, and sta

Compliance7 days ago

Title: Associate - Affordable Housing (at least 3 Years of experience) Location: Los Angeles, Indian Wells, Irvine, Manhattan Beach, Ontario, Riv, CA Job Description: Nationally recognized law firm has an immediate opening for an Associate - Affordable Housing, with at least three years of affordable housing and real estate experience. - This individual will work on all aspects of affordable housing transactional work, including joint venture work, conventional and bond-financed loan work (borrower side), purchase and sale agreements, and general real estate work involved in acquisitions and dispositions of real property. - Substantive legal experience in some or all of the following areas is highly desirable: housing tax credits, public housing redevelopment, HUD programs, and CDBG implementation programs. * MUST BE LICENSED IN CA. Locations: OPEN TO ANY OFFICE Northern CA: Sacramento and Walnut Creek Southern CA: Indian Wells | Irvine | Los Angeles | Manhattan Beach | Ontario | Riverside | San Diego Prospective employees have provided feedback to the client that one of the most impressive traits of the Firm is the congenial working atmosphere fostered by partners and associates alike. Position is currently REMOTE until further notice, however candidate should reside in the areas of the designated locations.

California
NORC at the University of Chicago logo

Senior IT Risk and Compliance Analyst

NORC at the University of Chicago

NORC at the University of Chicago is an objective, nonpartisan, nonprofit academic research organization serving the public interest by delivering objective ana

Compliance7 days ago

Title: Senior IT Risk and Compliance Analyst Location: Washington, DC - D.C. - Washington DC Job Description: JOB SUMMARY: NORC at the University of Chicago seeks Senior IT Risk and Compliance Analyst to join our DSS Security and Compliance group. The successful candidate will be part of an IT Risk and Compliance team, expert in government security standards and regulations. The successful candidate will be part of an IT Risk and Compliance team, expert in government security standards and regulations. The team is responsible for specifying, documenting, validating, and maintaining IT security & privacy controls to ensure compliance with security requirements of clients (principally Government) and corporate standards for data and systems integrity. The team develops and implements tools and processes to measure and track IT risk and compliance metrics. The team provides guidance to IT functional teams on risk and compliance as it pertains to system development, documentation, testing, monitoring, and reporting. The team conducts risk assessments and security impact analyses of information systems.   Location: This is a hybrid role based in our Chicago Loop or Washington, DC office, with a minimum of six days per month in the office. Remote candidates may also be considered. Qualified applicants must be U.S. citizens due to security clearance requirements for projects. DEPARTMENT: Digital Services & Solutions Security & Compliance NORC's Digital Services & Solutions group provides technology services to our staff and clients. Given the critical role technology plays in our day-to-day lives, we are committed to providing professional, high-quality solutions in order to further our collective goal of advancing social science research. RESPONSIBILITIES: - Work with the team in specifying, documenting, validating, and maintaining IT security & privacy controls to ensure compliance with security. requirements of clients (principally Government) and corporate standards for data and systems integrity. - - Help develop and implement tools and processes to measure and track IT risk and compliance metrics. - - Provide guidance to IT functional teams on risk and compliance as it pertains to system development, documentation, testing, monitoring, and reporting. - - Assist the team with conducting risk assessments and security impact analyses of information systems. - REQUIRED SKILLS: Education and Certifications: - Bachelor’s degree in computer science, Information Technology, or a related field (or equivalent years of experience). - - Professional certifications such as Certified Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), or similar certifications. - General Experience: - Minimum of 4 years of experience in information security roles, emphasizing security architecture and engineering solutions. - - Proven experience in performing network penetration testing, vulnerability scans, and configuration analysis. - - Experience overseeing project penetration testing activities. - - Preferred experience as an ISO for federal programs and projects. - - Experience coordinating communications across vendors, internal stakeholders, and program owners. - - Experience using CSAM - ATO Experience: - In-depth knowledge and experience guiding information systems through the Authorization to Operate (ATO) process: - - Proficient in navigating the complex landscape of ATO processes, demonstrating a successful track record in obtaining authorizations for information systems - - Extensive knowledge of the steps involved in the ATO process, ensuring compliance with government regulations and standards, including NIST Special Publications and FISMA - - A proven ability to streamline and expedite ATO timelines without compromising security standards, showcasing efficiency in documentation and regulatory adherence - - Expertise in developing and presenting comprehensive ATO documentation, including System Security Plans, to accrediting authorities and other relevant stakeholders - - Demonstrated skill in addressing and mitigating security risks identified during the ATO process, ensuring the secure operation of systems in various environments - - Exceptional communication skills to articulate ATO requirements, progress, and challenges to both technical and non-technical stakeholders, fostering collaboration and understanding. Risk Management Experience: - Demonstrated experience in developing threat models and security risk assessments. - - Ability to recommend mitigations and countermeasures to address identified risks, vulnerabilities, and threats. - - Experience conducting incident response across vendors, internal stakeholders, and program owners, including implementing, and coordinating the response plan, overseeing the technical response, and coordinating with legal, technical, and communications teams. Compliance and Documentation: - Thorough understanding and experience with government regulations and standards related to information security. - - In-depth knowledge of security compliance checks and the ability to perform audit activities. - - Experience in reviewing and validating security documentation, including system security requirements definition and System Security Plans. - - Experience conducting penetration testing across multiple vendors, contractors, and consultants that meet stringent client requirements. Communication and Guidance: - Strong communication skills with the ability to guide NORC customers on information security policies and regulations. - Ability to effectively communicate complex security concepts to both technical and non-technical stakeholders. SALARY AND BENEFITS: The pay range for this position is $97,000 - $120,000. This position is classified as regular. Regular staff are eligible for NORC’s comprehensive benefits program. Benefits include, but are not limited to: - Generously subsidized health insurance, effective on the first day of employment - Dental and vision insurance - A defined contribution retirement program, along with a separate voluntary 403(b) retirement program - Group life insurance, long-term and short-term disability insurance - Benefits that promote work/life balance, including generous paid time off, holidays; paid parental leave, bereavement leave, tuition assistance, and an Employee Assistance Program (EAP). NORC is committed to equity and transparency in its pay practices. We publish salary ranges and benefit information for every job. The listed hiring range reflects what we, in good faith, expect to pay at the time of posting, though actual compensation may vary and may be adjusted over time. A candidate’s placement within the range depends on factors such as competencies, education, qualifications, experience, skills, performance, and organizational needs. WHAT WE DO: NORC at the University of Chicago is an objective, non-partisan research institution that delivers reliable data and rigorous analysis to guide critical programmatic, business, and policy decisions. Since 1941, our teams have conducted groundbreaking studies, created and applied innovative methods and tools, and advanced principles of scientific integrity and collaboration. Today, government, corporate, and nonprofit clients around the world partner with us to transform increasingly complex information into useful knowledge. WHO WE ARE: For over 80 years, NORC has evolved in many ways, moving the needle with research methods, technical applications and groundbreaking research findings. But our tradition of excellence, passion for innovation, and commitment to collegiality have remained constant components of who we are as a brand, and who each of us is as a member of the NORC team. With world-class benefits, a business casual environment, and an emphasis on continuous learning, NORC is a place where people join for the stellar research and analysis work for which we’re known, and stay for the relationships they form with their colleagues who take pride in the impact their work is making on a global scale. EEO STATEMENT: NORC is an equal opportunity employer. NORC evaluates qualified applicants without regard to race, color, religion, sex, gender, national origin, disability, status as a protected veteran, sexual orientation, and other legally protected characteristics. #LI-MS1

Illinois + 1 moreAll locations: Illinois | District Of Columbia
$97K - $120K / year
New Hampshire Mutual Bancorp logo

Compliance Analyst – 2

New Hampshire Mutual Bancorp

A steward of mutual banking values in local communities throughout NH. Join our team! www.nhmutual.com/careers

Compliance7 days ago
Full TimeRemoteTeam 501-1,000Since 2013H1B No Sponsor

• Conduct risk-based compliance monitoring, testing, and documentation for retail banking, lending, HMDA, and operational compliance areas • Support HMDA LAR data integrity through validation, exception research, remediation tracking, and annual submission support • Analyze compliance issues, identify root causes and trends, and recommend practical corrective actions • Prepare workpapers, testing results, compliance metrics, issue summaries, and management-ready documentation • Partner with business lines, Compliance Management, audit, and examination stakeholders to communicate findings and support timely remediation • Assist with regulatory change management, including research, impact assessments, procedure updates, testing, and implementation documentation

New Hampshire
$60K - $72K / year
ContractRemoteTeam 1,001-5,000Since 1993H1B No Sponsor

• Support SOX year‑end and quarter‑end close‑out activities, including: o Evidence finalization and quality review o Control testing close‑out coordination o Deficiency and remediation tracking • Respond to auditor follow‑up requests and inquiries • Ensure SOX documentation and evidence are complete, accurate, and audit‑ready • Support SOC 2 audit execution, including: o Evidence coordination and submission o Control documentation maintenance o Tracking and responding to auditor requests • Assist with remediation documentation and management responses, as needed • Assist with ISO 27001 ISMS program development and enhancement, including: o Supporting policy, procedure, and control documentation o Aligning controls and evidence to ISO requirements o Preparing materials for readiness or certification activities • Support internal stakeholders operationalizing ISO 27001 requirements • Support ISO 27701 (Privacy Information Management System) build‑out, including: o Documentation of privacy controls, roles, and responsibilities o Mapping privacy requirements to existing ISO 27001 controls where applicable o Supporting evidence collection and audit readiness • Assist with broader data privacy compliance efforts, including: o Maintaining privacy documentation and evidence o Supporting privacy risk assessments and compliance tracking • Support EU AI regulatory readiness and AI governance initiatives, including: o Assisting with AI use case inventory and documentation o Supporting AI risk assessments and governance workflows o Aligning organizational practices to ISO 42001 (AI Management System) requirements • Assist with development of AI policies, procedures, and compliance artifacts • Provide hands‑on administration of Hyperproof, including: o Managing evidence requests and workflows o Maintaining control, framework, and evidence mappings o Supporting auditor portals and compliance dashboards • Ensure data quality and consistency across programs and framework • Support management of the KnowBe4 security awareness training program, including: o Campaign execution and tracking o Completion monitoring and reporting o Supporting audit and compliance evidence needs • Monitor and manage the privacy inbox, including: o Assist in intake, triage, and tracking of privacy‑related requests o Oversee coordination with Legal, Security, and IT stakeholders o Ensuring timely and documented responses

Canada
$16.6K / month
Job Closed