Ipsen

Senior Manager, CMC Regulatory

Ipsen

full-time

Posted on:

Location Type: Hybrid

Location: Paris • 🇫🇷 France

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Job Level

Senior

About the role

  • Responsibility for CMC regulatory strategy for the assigned biological projects throughout the different phases of development from early clinical trials to initial marketing applications
  • Manage the CMC Regulatory relationship for the assigned product(s)/projects with Ipsen’s GRA LT, manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO) SMEs and LT
  • Provide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers
  • Lead the development of CMC regulatory strategy for the assigned projects
  • Collaborate closely with Pharmaceutical Development and / or Technical Operations teams, to generate effective CMC regulatory dossiers
  • Ensure that regulatory requirements are met
  • Anticipate any gaps for planned regulatory submissions
  • Propose innovative CMC regulatory pathways to accelerate product delivery for patients as required
  • Manage all Regulatory interactions for Site Registrations, Site Licenses, Site master files, annual reports and site accreditations with Regulatory Authorities, Alliance partners, and CMOs for assigned product(s) as applicable

Requirements

  • Proven direct experience in CMC regulatory environment in pharmaceutical industry dealing with Biological/Biotechnological modalities (approximately 8 - 10 years’ experience)
  • Proven experience in managing CMC-regulatory activity for products in a worldwide environment
  • Proven experience in CMC regulatory on R&D and/or LCM portfolio
  • Experience of Health Authorities interaction
  • Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions
  • Proven ability to learn respect in a cross-functional global environment
  • Proven understanding of CMC regulatory processes and requirement in US, EU, and export countries (e.g. JP, China, Brazil, Russia)
  • Excellent written, verbal and interpersonal communication skills, highly organized
  • Ability to handle multiple priorities and complex projects in a fast-paced environment
  • Strong analytical and problem-solving skills
  • Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)
  • English: fluent
  • French fluent
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
CMC regulatory strategyregulatory writingeCTD formatsbiological projectspharmaceutical developmenttechnical operationsregulatory submissionssite registrationssite licensesregulatory processes
Soft skills
communication skillsorganizational skillsanalytical skillsproblem-solving skillsability to handle multiple prioritiescross-functional collaborationleadershipinterpersonal skillsadaptabilityattention to detail
Certifications
advanced degree in scientific discipline