Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

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

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have based in Switzerland.

We are seeking an experienced Regulatory CMC Consultant to support regulatory affairs activities for small-molecule pharmaceutical products. In this senior consulting role, you will apply your expertise in regulatory requirements, drug development, and product lifecycle management to help ensure products remain compliant throughout their time on the market. You will assess regulatory guidelines, support ongoing regulatory obligations, and contribute to effective reporting and surveillance processes. Working in a collaborative, international life sciences environment, you will partner with cross-functional teams to address complex regulatory needs. This opportunity is suited to a knowledgeable professional who can combine strong technical judgment with clear communication and organized project execution.

Accountabilities:

You will provide senior-level regulatory CMC expertise, supporting the maintenance and regulatory oversight of pharmaceutical products while ensuring activities align with applicable North American requirements. Your responsibilities will include:

  • Support regulatory affairs activities for small-molecule pharmaceutical products, with a focus on Chemistry, Manufacturing, and Controls (CMC) requirements.

  • Apply knowledge of the North American regulatory framework to support product compliance and lifecycle activities.

  • Contribute to processes for maintaining products on the market, including regulatory reporting and ongoing surveillance.

  • Interpret and assess relevant regulatory guidelines and requirements, translating them into practical recommendations.

  • Apply an understanding of drug development principles and related regulatory concepts to assigned projects.

  • Collaborate with internal teams and stakeholders to address regulatory questions and support project deliverables.

  • Plan, prioritize, and organize work efficiently to meet project objectives and deadlines.

  • Communicate regulatory information, findings, and recommendations clearly to technical and non-technical stakeholders.

Requirements

The ideal candidate combines extensive pharmaceutical or biotechnology industry experience with strong knowledge of regulatory affairs and the ability to work effectively in a consulting environment. Required qualifications include:

  • Bachelor's, Master's, or PhD degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs, or another life sciences discipline.

  • Typically, at least 8 years of experience in the pharmaceutical or biotechnology industry, regulatory affairs, or a related field, or an equivalent combination of education and experience.

  • Strong knowledge of the North American regulatory affairs framework.

  • Experience or sound understanding of regulatory requirements and processes for maintaining marketed products, including reporting and surveillance.

  • Good understanding of drug development and associated regulatory concepts.

  • Ability to interpret, evaluate, and apply regulatory guidelines.

  • Excellent written and verbal communication skills.

  • Strong organizational and time-management skills, with the ability to plan, prioritize, and contribute to multiple tasks and projects systematically.

  • Ability to work collaboratively and contribute effectively within cross-functional teams.

Additional Preferred Expertise
  • Hands-on experience with small-molecule CMC regulatory activities.

  • Practical experience using Veeva RIM, which is specifically required for this opportunity.

Benefits
  • Opportunities to collaborate with international experts across the biopharmaceutical industry.

  • Access to professional development, career progression, and technical and therapeutic-area training.

  • Supportive and engaged line management.

  • Peer recognition and a comprehensive total rewards program.

  • Exposure to emerging technologies, scientific knowledge, and complex regulatory challenges.

  • Opportunities to explore different career paths within a growing global organization.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice:

By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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