Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

0

Seniority

Senior

Bachelor Degree6 yrs expEnglishApollo

Job Description

Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

Parexel

• Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE). • Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile. • Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership. • Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities. • Remain current with global labeling regulations and provide training to internal stakeholders. • Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation. • Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. • Support regional implementation of CDS updates and monitor compliance across markets. • Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.

Job Requirements

  • Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
  • 5-7 years in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with global strategic leadership responsibilities.
  • Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
  • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
  • Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
  • Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
  • Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
  • Fluency in English (verbal and written); additional languages would be an asset.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible working hours
  • Paid time off
  • Professional development opportunities

Related Categories

Related Job Pages

More Compliance Jobs

The Quality Group logo

Senior Food Regulatory Manager

The Quality Group

Marken: ESN, More Nutrition, Foodist

Compliance5 days ago
Full TimeRemoteTeam 1,001-5,000Since 2021H1B No Sponsor

• You assess our products for marketability/compliance in the EU and the USA • You review product descriptions and marketing copy for compliance with food laws and regulations • You collaborate during product conception, development and launch preparation with Product Management, R&D, Business Development, Marketing and Customer Support on food regulatory matters • You monitor changes in food legislation and derive and implement appropriate measures for the affected departments • You handle official regulatory findings and coordinate responses to authorities • You are responsible for product notifications

Germany
Compliance5 days ago
Full TimeRemoteTeam 201-500Since 2004H1B No Sponsor

• You assess our products for marketability and regulatory compliance in the EU and the USA • You review product descriptions and marketing copy for compliance with food law • You collaborate with Product Management, R&D, Business Development, Marketing and Customer Support during product conception, development and launch preparation on food law-related issues • You monitor changes in food legislation and translate them into appropriate actions for the affected areas • You handle regulatory objections and official inquiries • You manage product notifications

Germany

Director of Enrollment Compliance

Regent University

Based in Virginia Beach, Virginia, Regent University is a faith-based institution of higher learning that seeks to train "Christian leadership to change the wor

Compliance6 days ago

Director of Enrollment Compliance Location: Virginia Beach - United States Job Description: The Director of Enrollment Compliance serves as the institution's primary subject matter expert and quality assurance manager for all federal reporting required by the Registrar's Office, to the National Student Loan Data System (NSLDS) to ensure compliance with applicable regulations. Work Location: Virginia Beach, VA (qualified candidates may be considered for remote work depending on location) Salary:$65,000 - $70,000 annually Essential duties: - Serve as the institutional lead for all NSLDS enrollment reporting, including managing submission cycles in accordance with federal requirements and any National Student Clearinghouse (NSC) participation agreements. - Tracks and monitors enrollment reporting transmissions from submission to completion to ensure adherence to the federal reporting obligation. - Establish, document, and quality check the date of determination for enrollment status changes and maintain accurate audit trails in the Student Information System, Banner, to support compliance and program reviews. This includes monitoring student record requests, such as add/drop forms. - Monitor NSC and NSLDS processing timelines and provide any necessary adjustments to ensure compliance timelines. - Resolve all enrollment reporting error reports in a timely manner, including the SSCR report. - Serve as a liaison between the Registrar's Office and the NSC, including escalating reporting issues in collaboration with the University Registrar, and between the University Registrar, Regent's internal auditor, and the Office of Financial Aid. - Perform quality assurance and control checks on enrollment data submissions to ensure accuracy and compliance, including pre-submission audits of enrollment data files. - Develop and maintain internal quality assurance procedures, checklists, and reconciliation workflows to reduce error rates and data consistency. - Monitor regulatory changes and updates to federal and state guidance to ensure full university compliance. - Create and maintain policy guides and training resources related to enrollment reporting for the Registrar's Office. - Manage the institution's Degree Verify reporting process through the NSC to ensure timely and accurate submission of degree conferral data in alignment with degree conferral cycle. Qualifications: - Bachelor's degree required - Master's degree preferred - Preferred degree in higher education administration, business, information systems, or related field - Minimum of three (3) years of direct experience with NSC / NSLDS enrollment reporting Candidates must have: - Demonstrated knowledge of federal enrollment reporting requirements under Title IV - Must be eligible to be recommended and approved to access the NSLDS - Proficiency with Ellucian Banner systems or comparable student information system - Strong analytical skills with high attention to detail and a commitment to data accuracy - Knowledge of FERPA regulations and its application to student records management - Data analytical skills to perform analyses and report utilizing software (e.g., Excel) - Commitment to Regent’s core values of Excellence, Innovation, and Integrity Regent University does not discriminate in employment in its programs or activities on the basis of race, color, national or ethnic origin, sex, disability, age or veteran status. For full Non-Discrimination Policy click here. Benefits Regent offers a wide range of generous benefits including health, life and disability insurance; flexible spending accounts; tuition incentives; fully vested retirement plans; life and disability insurance options, time off, and more. All regular faculty and staff serving at Regent and working a minimum of 30 hours per week will receive an attractive benefits package.

Virginia
$65K - $70K / year
Full TimeRemoteTeam 5,001-10,000H1B No Sponsor

• Maintain or create CMC regulatory documents for product submissions • Manage CMC regulatory documents in collaboration with the Core team • Advise project teams on regulatory agency requirements • Review change control requests pertaining to CMC aspects • Agree on regulatory strategy for GRD products' life cycle • Maintain submission information and track commitments • Work with external CMOs and cross-functional teams • Support development of processes and Standard Operating Procedures • Represent GRDRA during GMP inspections • Keep abreast of current regulatory CMC requirements

Italy
€46.8K / year
Job Closed