Sr. Manager, CMC Regulatory Affairs

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type:
Permanent

Location:

United States, US

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

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. Candidates based in USA, Canada and EU can be considered.

• 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. Track Wise) 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…