Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

This is what you will do

We are seeking a Senior Manager, CMC Regulatory Affairs, with direct experience in post-approval CMC activities to support Chiesi’s Global Rare Diseases (GRD) portfolio of commercial products worldwide.

You will be responsible for

• Author and/or review CMC sections for the assigned GRD portfolio, including new marketing authorization applications, extension applications, investigational applications, post-approval variations and supplements, renewals, and annual reports, ensuring timely, high-quality global submissions
• In alignment with the GRD RA CMC Senior Director and/or Lead, advise multidisciplinary project teams on regulatory agency requirements and expectations for the CMC sections of submission dossiers
• Collaborate with external contract manufacturing organizations (CMOs) and relevant functional teams to obtain the CMC documentation required to support regulatory submissions
• Support the development of regulatory strategies for assigned projects, in alignment with the GRD RA CMC Senior Director and Lead, including both products in development and marketed GRD products
• Prepare timely responses to CMC regulatory questions in coordination with cross-functional teams and subject matter experts (SMEs), as needed
• Work collaboratively with external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer activities
• Review and assess change control requests related to the CMC aspects of GRD products and coordinate the associated filing strategies
• Support the creation and maintenance of CMC submission templates
• Maintain submission information in accordance with the company’s document management system and independently track regulatory CMC commitments and timelines for assigned projects, products, and markets
• Contribute to process development and to the preparation of standard operating procedures and work instructions for the RA CMC team, as needed
• With the agreement of the GRD RA CMC Lead, represent GRD RA during regulatory agency GMP inspections
• Maintain current knowledge of applicable regulations, policies, and guidelines, and remain informed of evolving global CMC regulatory requirements

You will need to have

• Bachelor’s degree in a scientific or technical discipline required; an advanced degree is preferred
• Minimum of six years of regulatory CMC experience supporting small-molecule, herbal medicinal and/or biological products
• Advanced knowledge of current global CMC regulations and guidelines, including ICH requirements and applicable regulatory requirements in the United States, European Union, and Canada
• Demonstrated experience authoring technical documentation and CTD Modules 2 and 3, and managing the lifecycle of quality-related post-approval changes across international markets ex-US and ex-Europe
• Experience with quality management systems, such as TrackWise, and regulatory information and document management platforms, such as Veeva RIM, is considered an asset
• Exceptional attention to detail and a strong commitment to quality and accuracy
• Demonstrated ability to manage competing priorities, maintain strong organization, and consistently meet deadlines
• Excellent written, verbal, and interpersonal communication skills, supported by strong critical-thinking and problem-solving capabilities
• Proven ability to work effectively both independently and collaboratively within a dynamic, fast-paced, and cross-functional environment

Location

The role can be based in any Chiesi affiliates in Europe.

Budgeted Salary Range (package applied for role based in Italy)