Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

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Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Date: 1 Oct 2026

Department: GRD Regulatory Affairs

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma or Chiesi Affiliates in , IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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 is what 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 and inclusion 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.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here .

What we are looking for

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