Senior Regulatory CMC Consultant — Small-Mol & Veeva RIM

Jobgether

Schweiz

On-site

CHF 120,000 - 180,000

Full time

4 days ago
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Benefits offered by this job

International collaboration
Professional development and training
Supportive management
Total rewards program
Exposure to emerging technologies

Job summary

Jobgether, on behalf of a partner in Switzerland, seeks a Sr Regulatory CMC Consultant to support regulatory CMC for small-molecule products and ensure compliance with North American requirements within a global life sciences setting.

The role emphasizes collaboration with cross-functional teams, effective regulatory reporting, and timely project execution. Prior experience with Veeva RIM is highly valued.

Qualifications

  • Bachelor's/Master's/PhD in life sciences or related field.
  • 8+ years in pharmaceutical/biotech/regulatory affairs or equivalent.
  • Strong knowledge of North American regulatory affairs framework.
  • Experience with regulatory requirements for marketed products, including reporting and surveillance.
  • Understanding of drug development and regulatory concepts.
  • Ability to interpret and apply regulatory guidelines.
  • Excellent written and verbal communication skills.
  • Strong organizational and time-management skills; able to manage multiple tasks.

Responsibilities

  • Provide senior-level regulatory CMC expertise supporting maintenance and oversight of products for North American markets.
  • Apply knowledge of NA regulatory framework to support compliance and lifecycle activities.
  • Contribute to processes ensuring products remain on the market, incl. regulatory reporting and surveillance.
  • Interpret and assess guidelines, translating into practical recommendations.
  • Apply drug development principles to projects and deliverables.
  • Collaborate with internal teams to address regulatory questions and deliverables.
  • Plan and prioritize work to meet objectives and deadlines.
  • Communicate regulatory findings clearly to technical and non-technical stakeholders.

Skills

Regulatory affairs expertise
Cross-functional collaboration
Regulatory interpretation
Communication skills
Project management

Education

Life sciences degree (BSc/MSc/PhD)

Tools

Veeva RIM

Job description

Jobgether, on behalf of a partner in Switzerland, seeks a Sr Regulatory CMC Consultant to support regulatory CMC for small-molecule products and ensure compliance with North American requirements within a global life sciences setting.

The role emphasizes collaboration with cross-functional teams, effective regulatory reporting, and timely project execution. Prior experience with Veeva RIM is highly valued.

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