Job Closed

This listing is no longer active.

ProKidney Corp. logo
ProKidney Corp.

A Step Closer to Potential Dialysis Prevention

Regulatory Manager – CMC

ComplianceComplianceOtherRemoteSeniorTeam 51-200Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

107 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Regulatory Manager – CMC

ProKidney Corp.

• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, and amendments. • Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions. • Maintain and track regulatory submission timelines and deliverables. • Support responses to health authority information requests related to CMC topics. • Review and assess change controls to determine potential regulatory impact and filing requirements. • Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies. • Help ensure documentation and submissions meet current regulatory standards and internal quality requirements. • Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs. • Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff. • Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities. • Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation.

Job Requirements

  • Bachelor’s or master’s degree in a scientific or engineering discipline (e.g., biology, chemistry, biochemistry, pharmaceutical sciences).
  • 5+ years of experience in Regulatory Affairs or related experience in Manufacturing, QA, or QC in a biotech/pharmaceutical environment.
  • Exposure to CMC regulatory filings (INDs, CTAs, or amendments) preferred.
  • Experience in cell or gene therapy is a plus, but not required.
  • Understanding of the drug development process and the role of CMC in regulatory submissions.
  • Familiarity with ICH guidelines and US/global regulatory requirements.
  • Strong organizational and communication skills.
  • Detail-oriented with a focus on quality and accuracy.
  • Ability to manage multiple tasks and timelines in a dynamic environment.
  • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and document management systems.

Benefits

  • Equal employment opportunity employer
  • Does not discriminate against any applicant

Related Categories

Related Job Pages

More Compliance Jobs

GoTo logo

Staff GRC Compliance Analyst

GoTo

Making IT easy, anywhere.

Compliance107 days ago
OtherRemoteTeam 1,001-5,000Since 2000H1B Sponsor

• Serve as a staff level, cross-trained GRC expert across Compliance, Audit, and Risk, partnering with teams to strengthen trust and resilience across the business • Perform control mapping, gap analysis, and remediation tracking across multiple frameworks to proactively reduce audit risk • Partner with engineering, IT, and security teams to translate regulatory requirements into actionable, testable technical controls • Identify and operationalize improvements to the control framework to align with evolving regulatory demands (e.g., NIS2) • Reduce manual audit friction by driving process improvement and leveraging automation (dashboards, workflows, tooling integrations)

Florida + 2 moreAll locations: Florida | Massachusetts | Tennessee
$130K - $173K / year
Job Closed
OtherRemoteTeam 501-1,000Since 2016H1B Sponsor

• Lead Remitee’s regional licensing roadmap, prioritizing market entry and product expansion needs. • Drive regulatory gap assessments for new markets, new flows, new products, and partner-led models. • Coordinate licensing deliverables including business plans, compliance manuals, governance frameworks, policies, procedures, risk matrices, and operational narratives required by regulators. • Prepare and oversee formal filings and submissions to regulators, supervisory bodies, and central banks. • Act as Remitee’s senior point of contact for: regulatory inquiries, RFIs, remediation plans, exams, audits, and periodic reporting. • Translate licensing conditions and regulatory obligations into operational controls, workflows, and scalable compliance-by-design processes. • Partner with Compliance and Legal to ensure robust coverage across: AML/CTF, KYC/CDD, consumer protection, payments/FX controls, fraud risk, data privacy, outsourcing management. • Work with Product & Tech teams to embed regulatory requirements into product design and system capabilities. • Build and maintain trusted relationships with regulators and relevant industry associations. • Advise executive leadership on regulatory risk, strategic trade-offs, and expansion feasibility. • Support Business Development in partner onboarding, due diligence, regulatory documentation, and licensing-driven commercial negotiations. • Build and maintain regulatory playbooks, internal policies, and licensing documentation repositories. • Drive continuous improvement to streamline licensing processes and reduce time-to-approval. • Train internal teams on regulatory obligations and evolving standards across jurisdictions.

United States
Job Closed
Better logo

Audit Analyst – Regulatory

Better

Making homeownership simpler, faster - and most importantly, more accessible. NMLS #330511 | better.com/terms

Compliance107 days ago
Full TimeRemoteTeam 1,001-5,000Since 2016H1B Sponsor

• Support the Regulatory Strategy & Operations (RSO) team in executing loan-level compliance testing, regulatory reporting audits, and examination readiness activities. • Perform detailed loan file reviews to validate accuracy of data reported in regulatory filings and internal systems. • Execute predefined audit scripts and testing procedures across HMDA, MCR, and state reporting datasets. • Compare source documentation against reported data fields to identify discrepancies. • Document findings clearly and consistently in accordance with internal audit standards. • Support testing of regulatory reporting processes, including HMDA LAR and Mortgage Call Reports. • Assist in reconciliation reviews and control validations to ensure reporting completeness and accuracy. • Escalate identified data issues and collaborate with internal stakeholders on corrective actions. • Maintain structured audit workpapers and testing documentation. • Prepare loan files and supporting documentation for internal reviews and state/federal examinations. • Track document requests and assist in compiling responses for regulatory inquiries. • Support remediation tracking by validating corrective actions and follow-up testing. • Conduct structured analysis to identify reporting trends, operational breakdowns, and control gaps. • Support root cause validation by reviewing loan documentation and system data. • Partner with Operations, Compliance, and Reporting teams to resolve discrepancies. • Contribute to the refinement of audit scripts, checklists, and monitoring frameworks. • Identify opportunities to improve documentation, testing efficiency, and control reliability.

India
Marqeta logo

Senior Risk and Compliance Analyst

Marqeta

Headquartered in Oakland, California, Marqeta created an open application programming interface (API) to help simplify the way payment programs are managed. The

Compliance107 days ago

• Assist with providing compliance advisory support to Product, Marketing, Legal, Sales, and other departments throughout product and campaign lifecycles • Provide comprehensive understanding of relevant consumer finance regulations (including Reg Z, V, DD, CC, B, E, etc.), industry standards, and internal policies • Monitor and assess external industry trends and regulatory environment to help shape Marqeta's compliance strategy • Assist with regulatory responses and compliance advisory duties, as needed • Support change management reviews for new products, features, or program changes • Assist with formal review process for external customer marketing content and campaigns including advertisements, promotional content, digital media, social media and product information, to ensure compliance with legal and regulatory requirements, including UDAP/UDAAP, and FTC advertising rules • Coordinate with Legal, Marketing, and other departments to obtain necessary approvals and feedback • Assist in reviewing products and services for compliance with applicable federal and state consumer-finance laws and bank partner requirements • Maintain awareness of compliance risks associated with client-specific product constructs • Develop, maintain and update consumer compliance policies and procedures in response to changes in regulations and business needs, as needed. • Assist with other compliance advisory duties, as needed.

United States
$112K - $140K / year
Job Closed