Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Chiesi Farmaceutici•Boston, MA

1d•Hybrid

About The Position

Chiesi Global Rare Diseases is a business unit of the Chiesi Group focused on the research, development, and commercialization of treatments and patient support services for rare and ultra-rare disorders. This unit, based in Boston, Massachusetts, with synergy with the headquarters in Parma, Italy, concentrates on lysosomal storage diseases, rare hematology, ophthalmology disorders, and rare immunodeficiencies. The unit collaborates with global leaders in scientific research, patient advocacy, and care. The Senior Manager, CMC Regulatory Affairs will support the global portfolio of commercial products for Chiesi's Global Rare Diseases unit, with a focus on pre and post-approval CMC regulatory affairs.

Requirements

Minimum of a bachelor’s degree in a Scientific or Technical Discipline.
5 + years of Regulatory CMC experience.
Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
Sound knowledge of manufacturing technical transfer and comparability regulatory requirements.
Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system.
Strong attention to detail.
Ability to multi-task, stay organized and prioritize.
Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.
Ability to work independently and in a group setting and thrive in a fast-paced environment.

Nice To Haves

Advanced Degree in a Scientific or Technical Discipline.

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 authorization applications, investigational applications and variations/supplements, worldwide.
Advise multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossiers.
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 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.