Senior Regulatory CMC Lead – Small Molecule & Veeva RIM

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

Job summary

Jobgether is seeking a Sr Regulatory CMC Consultant based in the Netherlands to lead regulatory CMC activities for small-molecule programs. You will apply regulatory expertise, ensure product lifecycle compliance, and collaborate with global teams in a fast-paced consulting environment.

This senior role focuses on interpreting North American regulatory requirements, maintaining marketed products, and contributing to reporting and surveillance.

Qualifications

• At least 8 years in pharmaceutical/biotech regulatory affairs or a related field.
• Strong knowledge of North American regulatory framework.
• Experience in regulatory activities for maintaining marketed products, including reporting and surveillance.
• Excellent written and verbal communication skills.

Responsibilities

• Provide senior-level Regulatory CMC expertise for small-molecule products.
• Support compliance with North American regulatory requirements.
• Maintain regulatory oversight and lifecycle activities for marketed products.
• Interpret regulatory guidelines and translate into actionable recommendations.
• Collaborate with cross-functional teams to address regulatory questions.
• Plan, prioritize, and organize work to meet deadlines.
• Communicate findings clearly to technical and non-technical stakeholders.

Skills

Regulatory affairs

Communication

Project management

Cross-functional collaboration

Drug development knowledge

Education

Bachelor's/Master's/PhD in life sciences

Tools

Veeva RIM

Job description

Jobgether is seeking a Sr Regulatory CMC Consultant based in the Netherlands to lead regulatory CMC activities for small-molecule programs. You will apply regulatory expertise, ensure product lifecycle compliance, and collaborate with global teams in a fast-paced consulting environment.

This senior role focuses on interpreting North American regulatory requirements, maintaining marketed products, and contributing to reporting and surveillance.