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Chiesi USA, Inc. · 3 days ago

Sr. Manager, CMC Regulatory Affairs

United States

Full-time

Remote

Mid, Senior Level

$121K/yr - $182K/yr

7+ years exp

Chiesi USA, Inc. is an international biopharmaceutical group focused on promoting a healthier world through innovative drug development. They are seeking a Senior Manager in Regulatory Affairs with expertise in CMC to support their Global Rare Diseases portfolio, managing regulatory documents and collaborating with cross-functional teams.

BiotechnologyMedicalPharmaceutical

Responsibilities

Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategy

Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervision

Act as the GRDRA CMC representative at core team level with a global role, where required

Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide

Advise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier

Review and assess change control requests pertaining to CMC aspects of GRD product(s)

In alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life cycle and development

Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision

Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities

In agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier

Support the development of processes and to the preparation of Standard Operating Procedures where required

Support due diligence activities on CMC regulatory documents, where required

Represent GRDRA during GMP inspections by regulatory agencies, where required

Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements

Qualification

Regulatory CMC experienceGlobal CMC regulationsTechnical document authoringQuality management softwareMulti-taskCommunication skillsAttention to detailCritical thinking