Manager, CMC Regulatory Affairs, Global Rare Diseases

Chiesi Group•Cary, NC

2d•$121,000 - $182,000•Hybrid

About The Position

This role is for a Regulatory Affairs (RA) Manager with strong CMC pre and post-approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products. The position is based in Cary, NC and is a hybrid role. Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. The company emphasizes promoting a healthier world for people, patients, and the planet, driving sustainable innovation with purpose, and fostering a culture of reliability, transparency, and ethical behavior. Chiesi is a Benefit Corporation and a certified B Corp, with sustainability embedded in its bylaws. Diversity, inclusion, and equal opportunity are core values. Chiesi Global Rare Diseases is a business unit focused on research, development, and commercialization of treatments and patient support services for rare and ultra-rare disorders, with a focus on lysosomal storage diseases, rare hematology, ophthalmology disorders, and rare immunodeficiencies.

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 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.