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CORAT Therapeutics GmbH is a clinical phase biopharmaceutical company founded in May 2020. The company is dedicated to developing therapeutic products to fight SARS-CoV-2 mediated COVID-19 disease and help to cure COVID-19 affected people suffering from this disease. The lead product COR‑101 is under investigation in the clinical phase Ib/II, currently.

To support the CORAT team within the ongoing COR-101 program as well as the development of further product candidates, CORAT is seeking for a new team member.


Aufgaben

The Director Regulatory Affairs is supporting the company in all aspects of Regulatory Affairs, including CMC, non-clinical and clinical development as well as marketing authorization related activities of therapeutic antibodies within the company’s product pipeline. The Director acts as a link between CORAT and regulatory authorities in combination with the CMO/CEO, ensuring that products are developed, manufactured, and distributed in compliance with appropriate legislative requirements.

Scope & responsibility

  • Development of regulatory strategy including CMC; non-clinical and clinical trial strategies as well as marketing authorization applications.
  • Represent Regulatory Affairs for the assigned portfolio at management and external stakeholder levels.
  • Oversee all Regulatory Affairs programs and projects, guide teams to ensure cross-functional integration, coordination, and alignment.
  • Provide leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools, and other resources.
  • Plan and oversee department budget.

Overall team’s responsibility:

  • Ensure compliance with regulations, guidelines, and ICH as required by the Health Care Agencies in Europe (EMA) and the US (FDA), and potentially additional regions.
  • Prepare and review clinical trial applications (CTA) to both Ethics Committees and Competent Authorities. 
  • Gather, evaluate, organize, manage, and collate information in a variety of formats, including trial data.
  • Maintain familiarity with company products.
  • Plan, undertake and oversee product trials and regulatory inspections.
  • Keep up to date with changes in regulatory legislation and guidelines.
  • Offer advice about company policies, practices, and systems.
  • Outline requirements for labelling, storage, and packaging.
  • Liaise and negotiate with regulatory authorities.
  • Provide advice about regulations to manufacturers and scientists.
  • Prepare regulatory filings for marketing authorizations.
  • Write comprehensible, user-friendly, clear product information leaflets and labels.
  • Ensure that quality standards are met, and submissions meet strict deadlines.
  • Prepare any relevant documentation.
  • Develop and author SOPs.

Profil

Education/Qualifications

  • Completed studies in chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science.

Experience, Skills, Knowledge

  • At least 5 years of experience in Regulatory Affairs in a Biopharmaceutical or Biotechnology Development environment.
  • Leadership/management experiences.
  • Very good knowledge of English written and oral.

Wir bieten
  • A full-time job (40 hrs./week).
  • Flexible working hours.
  • The possibility to work independently.
  • The opportunity to make a significant contribution to fight COVID-19 pandemic.
  • Highly enthusiastic team and collegial atmosphere.