Sr. Manager, CMC Regulatory Affairs

Currently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi's Global Rare Diseases (GRD) global portfolio of commercial products.

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• 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.

• 7 + years of Regulatory CMC experience in Biologics, Small Molecules, Herbal Medicinal Products
• Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
• Sound knowledge of technical transfer 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 is an asset.
• Strong attention to detail.
• Proven 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.

Minimum of a bachelor's degree in a Scientific or Technical Discipline; Advanced Degree preferred.

The annual base pay for this position ranges from $121,000 to $182,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.