Senior Manager, CMC Regulatory Affairs – Global Rare Diseases

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversee the creation and maintenance of CMC regulatory documents for specific product(s) to facilitate a wide array of submissions to Regulatory Authorities, in alignment with the GRDRA strategy.

• Manage CMC regulatory documentation for dedicated product(s) in close partnership with the Core team and GCST, taking full ownership with minimal supervision.

• Serve as the GRDRA CMC representative at the core team level in a global capacity, as needed.

• Author and/or review CMC sections of the specific GRD portfolio for new marketing authorization applications, investigational applications, and variations/supplements globally.

• Provide guidance to multidisciplinary project teams regarding regulatory agency expectations and requirements for the CMC sections of submission dossiers.

• Review and evaluate change control requests related to CMC aspects of GRD product(s).

• Collaborate with GRDRA CMC functions, GRDRA regional functions, and the Senior Director or Reg CMC Lead to establish the regulatory strategy for the life cycle and development of GRD products.

• Maintain submission information in accordance with the document management system, while tracking regulatory CMC commitments and timelines for specific projects/products/markets with minimal oversight.

• Collaborate effectively with external CMOs and cross-functional teams on projects such as process optimizations, scale-up, and technology transfer activities.

• In partnership with GRDRA CMC functions and working with GRDRA regional functions, negotiate strategies and actions with regulatory agencies concerning the CMC sections of submission dossiers.

• Assist in the development of processes and the preparation of Standard Operating Procedures as necessary.

• Support due diligence activities related to CMC regulatory documents, as needed.

• Represent GRDRA during GMP inspections by regulatory agencies, when required.

• Maintain a thorough understanding of regulations, policies/guidelines, and stay updated on current and evolving regulatory CMC requirements.

⛳️ Requirements

• A minimum of a bachelor’s degree in a Scientific or Technical Discipline; an Advanced Degree is highly preferred.

• At least 7 years of experience in Regulatory CMC, with a minimum of 3 years in Biologics/Biopharmaceuticals (candidates lacking Biologics experience will not be considered).

• Advanced understanding of current global CMC regulations, including ICH requirements and US/EU regulatory standards.

• Strong knowledge of regulatory requirements pertaining to manufacturing technical transfer and comparability.

• Proven experience in authoring technical documents, including CTD M2 and M3 sections, as well as managing the life cycle of quality variations.

• Proficient in utilizing quality management software (e.g., TrackWise) and regulatory document information management systems.

🏝️ Benefits

• Comprehensive healthcare programs.

• Work-life balance initiatives.

• Robust relocation support.

• Flexible working arrangements.

• Remote work options.

• Tax assistance services for foreign colleagues.