Senior Regulatory CMC Lead — Small Molecules & Veeva RIM

Jobgether; Italia; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Professional development

Career progression

Total rewards program

Exposure to international experts

Job summary

Jobgether is partnering with a client seeking a Sr Regulatory CMC Consultant for small-molecule products in Italy. The role focuses on CMC regulatory activities, NA framework, and lifecycle management within a global life sciences environment.

Ideal candidates have strong regulatory acumen, experience with drug development concepts, and excellent communication skills to support cross-functional teams and stakeholder engagement.

Qualifications

• Bachelor's, Master's, or PhD in Biology, Chemistry, Pharmacy or related life sciences field.
• At least 8 years in pharmaceutical/biotech regulatory affairs or equivalent.
• Strong knowledge of North American regulatory affairs.
• Experience with maintaining marketed products and regulatory reporting.
• Understanding of drug development and regulatory concepts.
• Ability to interpret and apply guidelines; strong written/verbal communication.
• Organizational and time-management skills; ability to manage multiple tasks.
• Collaborative, cross-functional team player.

Responsibilities

• Support regulatory affairs activities for small-molecule products focusing on CMC requirements.
• Apply knowledge of NA regulatory framework to support product compliance and lifecycle activities.
• Contribute to processes for maintaining products on the market, including reporting and surveillance.
• Interpret and translate regulatory guidelines into practical recommendations.
• Apply drug development knowledge to assigned projects.
• Collaborate with internal teams and stakeholders to address regulatory questions.
• Plan and organize work to meet deadlines.
• Communicate findings and recommendations clearly to technical and non-technical stakeholders.

Education

Bachelor's/Master's/PhD in Life Sciences

Regulatory affairs

CMC knowledge

North American regulatory framework

Excellent communication

Project management

Tools

Veeva RIM

Job description

Jobgether is partnering with a client seeking a Sr Regulatory CMC Consultant for small-molecule products in Italy. The role focuses on CMC regulatory activities, NA framework, and lifecycle management within a global life sciences environment.

Ideal candidates have strong regulatory acumen, experience with drug development concepts, and excellent communication skills to support cross-functional teams and stakeholder engagement.