This is what you will do

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

You will be responsible for

• 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.

You will need to have

• Minimum of a bachelor's degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred.
• 7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered)
• 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 syste

We would prefer for you to have

• 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.

Location

The position can be based anywhere in Europe with possibility of remote work.