Regulatory Service for non-API materials (m/w/d) – Freelance – onhold

  • Position zu besetzen ab 4. Oktober 2022
  • Permanent-ID OCR-FL-2028
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 8x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

As a consulting regulatory and quality expert, you work with the international product
management and the regulatory affairs department to develop strategy proposals for
the implementation of a regulatory and quality service concept.
To be able to grow pharma customer business, Consulting expertise to support the
biopharma raw material portfolio with the understanding, generation and
implementation of Drug Master Files (DMFs) for non-API raw pharma materials is
needed.

Task:
• Generate the documents and implement DMFs with different regulatory
bodies.
• Develop strategy proposals for regulatory support of non-APIs.
• Support the gap analysis of our GMP definition with the pharma/FDA GMP
definition

Experience:
• Biopharma consultant experience
• Knowledge of medical law
• Academic degree in medicine, pharmacy, biochemistry or a similar science
• Agile project Management skills

Requirements:
• Strong expertise in the generation and implementation of DMFs – especially for
nonAPI DMFs
• Expert knowledge in the GMP definition of the pharmaceutical industry
• Knowledge of IVD and pharma regulations as well as of medical law
• Contact to authorities in NAM, LATAM, EMEA and APAC
• Strong skills in technical writing
• Know-how of a regulatory affairs manager
• Strong management and negotiation skills
• Strategic and conceptual thinking
• Extensive project management experience
• Ability to work within a multicultural environment
• Fluent in English and German (written and verbal)

 

Additional Information:
Location: Bavaria
Project start: Oktober 2022
Project duration: 3 months with an option to
extend
Availability: 20-30h /week
Remote: ca. 90-100%

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