BeOne Medicines logo
BeOne Medicines

Cancer has no borders. Neither do we.

Senior Director, Regulatory Affairs, CMC

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

23 days ago

Salary

$204.5K - $274.5K / year

Seniority

Senior

Bachelor Degree12 yrs expEnglish

Job Description

• Lead and develop the U.S. Biologics Regulatory CMC team • Provide strategic and operational leadership for global biologics Regulatory CMC strategies • Partner closely with global cross-functional stakeholders on CMC regulatory strategies • Establish and continuously improve Regulatory CMC standard operating procedures (SOPs) • Ensure appropriate Regulatory CMC assessment throughout the product lifecycle • Review and approve Regulatory CMC documentation within the RIM system • Represent the company in external forums and regulatory or scientific conferences

Job Requirements

  • BA/BS Degree in scientific disciplines, MS/PhD preferred
  • 12+ years of relevant pharmaceutical or biopharmaceutical experience
  • At least 10 years of direct Regulatory CMC experience
  • Demonstrated track record of leading Health Authority interactions
  • Proven experience leading and developing teams of 10+ or more professionals
  • Advanced scientific training with hands-on expertise in at least one core pharmaceutical or biologics discipline
  • In-depth knowledge of ICH guidelines and global Regulatory CMC requirements
  • Extensive experience authoring, reviewing, and managing complex technical documentation

Benefits

  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

Related Categories

Related Job Pages

More Compliance Jobs

Block logo

Compliance Technology Oversight Lead

Block

Block builds simple, powerful tools that make progress towards an economy that’s truly open to all.

Compliance23 days ago
Full TimeRemoteTeam 10,001+Since 1990H1B Sponsor

Provide end-to-end technical oversight and effective challenge for compliance detection and AI models. Design monitoring frameworks, dashboards, and controls for transaction monitoring, sanctions screening, and risk scoring; lead incident management, regulatory-ready documentation, tuning/deprecation decisions, and cross-functional remediation.

Machine LearningHeuristic ModelsTransaction MonitoringSanctions ScreeningCustomer Risk ScoringAml Model ValidationSr 11-7Occ 2011-12Real-Time DashboardsData AnalyticsData VisualizationThreshold TuningInput Data Quality MonitoringModel Performance MonitoringAgile
California
Workstreet logo

Senior GRC Engineer – CMMC/FedRAMP

Workstreet

Best-in-class trust services for high-growth companies. Vanta’s biggest services partner.

Compliance23 days ago
Full TimeRemoteTeam 11-50Since 2023H1B No Sponsor

Senior GRC Engineer ensuring security compliance for clients

AWSAzureCloud
United States
Rainey Enterprises, LLC logo

Compliance Specialist

Rainey Enterprises, LLC

Rainey Enterprises, LLC provides individual, small business, and real estate services.

Compliance23 days ago
Full TimeRemoteTeam 1-10H1B No Sponsor

Affordable Housing Compliance Specialist ensuring regulatory compliance in affordable housing

California
$75K - $85K / year
Full TimeRemote

The Retail Compliance Manager is responsible for the development, execution, and oversight of the Retail Compliance Program to ensure our organization meets customer, retailer and industry compliance standards. This role provides strategic direction, ensures alignment across cros...

Project ManagementData AnalysisComplianceWarehouse SystemsTransportation SystemsData Integration
United States
$95K - $115K / year