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Senior Regulatory Affairs Associate – Local Regulatory Responsible Person

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

France

Posted

123 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expFrenchEnglishHashiCorp Vault

Job Description

Senior Regulatory Affairs Associate – Local Regulatory Responsible Person

Parexel

• Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams • Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements • Monitor status of submitted regulatory activities and ensure timely completion • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions • Ensure timely submission of renewals and mandated post-approval applications • Maintain RIMS database with current local activity and track compliance KPIs • Oversee compliant labelling (RCP, Notice, packaging) including updates, translations, and promotional material review • Act as primary RA representative for local Commercial Operations (ComOps) • Support regional regulatory TA teams within GRA for efficient planning and submission preparation • Collaborate with Global Labelling for Foundational Labelling Processes

Job Requirements

  • University degree in a life science discipline
  • Minimum 5 years' experience in French Regulatory Affairs
  • Strong understanding of French and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for French submissions
  • Experience with ANSM submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
  • Strong project management and leadership capabilities
  • Expertise in influencing stakeholders and driving business-critical decisions
  • Fluent in French and English (oral and written)

Benefits

  • Flexible work arrangements
  • Professional development opportunities

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