Associate Director Regulatory Affairs Small Molecules

Vor 2 Tagen

Visp, Schweiz TN Switzerland Vollzeit

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Associate Director Regulatory Affairs Small Molecules (f/m/d), VispClient:Location:Job Category:

Other

Job Reference:

3a4171bf38cf

Job Views:

10

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. We are looking for an Associate Director, Regulatory Affairs Small Molecules (f/m/d) to provide regulatory & strategic guidance (Regulatory Plans) to internal and external customers for our Small Molecules business.

Key responsibilities:

  1. Partner with internal and external stakeholders for the preparation (write and/or review) of high-quality CMC submissions that satisfy the critical regulatory criteria set by FDA, EMA, and/or other significant regulatory bodies.
  2. Proactively oversee the regulatory CMC aspects of programs, managing the preparation and ensuring the submission of CMC documentation supporting clinical trial applications and marketing submissions.
  3. Review and evaluate the regulatory impact of the change requests for the Small Molecule Drug Substances and Drug Products manufacturing process.
  4. Submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF) or other records on behalf of customers.
  5. Utilize prior analytical and/or manufacturing process experience to propose alternative solutions to challenges by internal and external customers.
  6. Apply a solution and service-minded proactive approach when dealing with challenging customers.

Key requirements:

  1. Degree in chemistry, biology, biochemistry, pharmacy or equivalent.
  2. Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules.
  3. Experience in leading small groups and complex programs.
  4. Exceptional communication and writing skills, fluency in English and German.

Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.

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