Senior Regulatory Affairs Manager CMC (INDs/IMPDs)

Your activities

  • Preparation of CMC-related submission documents (Modules 3 and 2.3) in compliance with current regulatory standards in support of clinical trial applications (e.g., INDs, CTAs) and applications for marketing of new drugs (e.g., NDA, MAA)
  • Preparation of CMC sections of briefing documents, responses to health authority inquiries, expedited designation applications, applications to obtain orphan drug designation, annual reports
  • Participation in and preparation of Pre-IND and Scientific Advice meetings (CMC aspects).
  • Research, analyze, and interpret CMC regulatory information and determine acceptability of data, procedures, and other product-related documents submitted in support of product approval
  • Actively collaborate with development teams, technical teams (manufacturing, supply chain, etc.) and quality department to prepare and implement robust CMC submission strategies for development and regulatory approval
  • Provide CMC regulatory expertise to internal departments (including R&D, manufacturing, quality assurance, quality control, marketing and clinical affairs) and external partners
  • Contribute to the preparation of product information (EU/FDA).

Your background

  • Successfully completed degree in pharmacy, chemistry, biochemistry, or biotechnology, a postgraduate degree would be an advantage
  • Solid experience with GMP regulations as well as regulatory requirements related to pharmaceuticals
  • 5-10 years of experience in a regulatory CMC role
  • Independent and responsible approach to work
  • Experience in working with therapeutic antibodies, or diagnostic drugs would be an advantage, preferably in both areas
  • Very good written and spoken English, German language skills would be a plus
  • Methodical competence, assertiveness
  • Reliable and emphatic manner, team-oriented
  • Confident handling of the common MS-Office programs

Your benefits

  • Family environment with plenty of room for development and creativity
  • Flexible working hours with working time recording and possibility to reduce overtime
  • High work-life balance, in particular good compatibility of family and career
  • Possibility to work almost exclusively remotely
  • Above-average compensation with many additional benefits (Christmas bonus, shares, company pension plan, training budget, etc.)
Gender note

For reasons of better readability the language forms masculine, feminine and diverse (m/f/*) are used simultaneously. All references to persons apply equally to all genders.

Type of contract

Permanent Position




Regulatory Affairs




Entry date






Capacity (FTE)


Your contact person
Karoline Gutensohn

Executive Recruiting Managerin


We are looking forward to your application!

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