Global CMC Regulatory Lead for Rare Diseases (Remote)

Chiesi Group; España; Hybrid; EUR 59,000 - 74,000; Full time

Job summary

Chiesi Group is seeking a Senior Manager, CMC Regulatory Affairs, to lead post-approval CMC activities for the Global Rare Diseases portfolio. You will collaborate with GRD RA CMC leadership and cross-functional teams to ensure global submissions.

The role emphasizes regulatory strategy, CMC documentation, and interactions with CMOs across international markets, with a focus on quality and timely delivery.

Qualifications

• Bachelor’s degree in a scientific or technical discipline; an advanced degree is preferred.
• Minimum of six years of regulatory CMC experience supporting small-molecule, herbal medicinal and/or biological products.
• Demonstrated experience authoring CTD Modules 2 and 3, and managing post-approval changes across international markets ex-US and ex-Europe.
• Experience with quality systems (TrackWise) and regulatory information systems (Veeva RIM) is an asset.

Responsibilities

• Author and/or review CMC sections for the GRD portfolio and ensure timely global submissions.
• Advise multidisciplinary project teams on regulatory requirements for CMC submissions.
• Collaborate with CMOs to obtain CMC documentation for submissions.
• Develop regulatory strategies for projects in development and for marketed GRD products.
• Prepare timely responses to CMC regulatory questions with cross-functional SMEs.
• Work with CMOs on process optimization, scale-up and technology transfer.
• Review change control requests related to CMC and coordinate filing strategies.
• Maintain submission information in the document management system and track CMC commitments.
• Contribute to SOPs and work instructions for the RA CMC team.
• Represent GRD RA during regulatory GMP inspections when agreed by Lead.

Skills

CMC regulatory

CTD Modules

ICH regulations

Technical documentation

Cross-functional collaboration

Attention to detail

Regulatory strategy

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

TrackWise

Veeva RIM

Job description

Chiesi Group is seeking a Senior Manager, CMC Regulatory Affairs, to lead post-approval CMC activities for the Global Rare Diseases portfolio. You will collaborate with GRD RA CMC leadership and cross-functional teams to ensure global submissions.

The role emphasizes regulatory strategy, CMC documentation, and interactions with CMOs across international markets, with a focus on quality and timely delivery.