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Join Our Team

We invest in our people because they are our greatest asset, a team of passionate experts shaping the future of healthcare regulation.

Health & Wellness

Comprehensive medical, dental, and vision insurance plus wellness programs

Career Growth

Clear advancement paths with mentorship and professional development opportunities

Remote Flexibility

Hybrid and remote work options to support your lifestyle and productivity

Work-Life Balance

Generous PTO, flexible hours, and company-wide wellness days

Learning Budget

Annual allowance for courses, conferences, and certifications

Collaborative Culture

Work with passionate experts in a supportive, inclusive environment

Open Positions

Find your next opportunity to make an impact

Regulatory Affairs Specialist - Biologics

ID: 2002

Global regulatory consultant specializing in BLA, biosimilar dossiers, and post-approval biologics lifecycle — managing pharmacovigilance integration and multi-agency interactions across concurrent client projects.

RemoteFull TIme
INDBLA (351(a) / 351(k))Biosimilar pathwayssBLABMFeCTD M1 - M5CTAMAACMAPSUR / PBRERICH S5–S9 / Q5US FDA (CBER)EMA EUA guideline complianceINDIA CDSCO Biologics GuidelinesForm 28-DHealth CanadaJAPAN PMDACMCPharmacovigilance (PV)Post-approval changes (PACMP)Comparability studiesmAbs / cell & gene therapyWHO prequalificationClinical Data IntegrationRegulatory Intelligence Validation

Regulatory Affairs Specialist - Pharmaceuticals

ID: 2001

Global regulatory consultant managing multi-market pharmaceutical submissions and lifecycle compliance across NDA, ANDA, eCTD, and equivalents — concurrently across client portfolios.

RemoteFull TIme
INDCTANDA / ANDA / MAAsNDAeCTD (M1–M5)DMFGMP / GLPICH Q8–Q12US FDA (CDER)EMA EUA guideline complianceINDIA CDSCO submissionsHealth Canada SNDSJAPAN PMDA J-NDAPost-approval variationsLabelling & SPCsRegulatory intelligenceParallel submission strategyUser acceptance testing