Regulatory Affairs CMC Associate Director
@ Novartis

Schaftenau, Tyrol, Austria
€120,000
On Site
Full Time
Posted 22 days ago

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Job Details

Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. Join Novartis as a Regulatory Affairs CMC Associate Director in Schaftenau, Austria (3 days per week on site) and help bring innovative therapies to patients faster.

About The Role

Key Responsibilities:

  • Formulate, lead, and drive global CMC regulatory strategy for Biologics or Small Molecules.
  • Coordinate global CMC submission activities including planning, authoring, and review.
  • Identify documentation needs and negotiate delivery of technical source documents.
  • Author and review high-quality CMC documentation for Health Authority submissions.
  • Represent Global Regulatory CMC on cross-functional project teams and maintain stakeholder partnerships.
  • Initiate and lead Health Authority interactions including briefing preparation and risk mitigation.
  • Provide strategic advice and direction within the department and cross-functional teams.

Essential Requirements

  • Science degree (Chemistry, Pharmacy, Biochemistry, etc.) or equivalent; advanced degree is a plus.
  • Minimum 8 years of regulatory or pharmaceutical industry experience.
  • In-depth understanding of regulatory submission and approval processes.
  • Ability to evaluate complex CMC regulatory issues across various scientific disciplines.

Why Novartis?

At Novartis, we reimagine medicine to improve and extend lives. You will receive a competitive base salary, an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities. Additional benefits can be found in the Novartis Life Handbook.

Commitment to Diversity & Inclusion

Novartis is committed to an inclusive work environment and diverse teams. Applicants requiring adjustments due to disabilities may contact disabilities.austria@novartis.com.

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Benefits and Rewards

Learn more about our comprehensive benefits and rewards by visiting our careers website.

Key skills/competency

  • regulatory
  • submission
  • strategy
  • documentation
  • compliance
  • negotiation
  • cross-functional
  • planning
  • technical
  • global
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How to Get Hired at Novartis

🎯 Tips for Getting Hired

  • Research Novartis culture: Study mission, values, news, and employee insights.
  • Customize your resume: Highlight relevant regulatory and CMC experience.
  • Tailor your cover letter: Emphasize global submission achievements.
  • Prepare for interviews: Review regulatory guidelines and strategic projects.

📝 Interview Preparation Advice

Technical Preparation

Review global CMC guidelines and submission processes.
Study recent FDA regulatory trends and documentation formats.
Practice authoring technical regulatory documents.
Familiarize with electronic submission systems and tools.

Behavioral Questions

Describe a challenging regulatory negotiation experience.
Explain a time you led a cross-functional project.
Discuss how you manage regulatory risks effectively.
Share an example of strategic planning under deadline pressure.

Frequently Asked Questions