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.
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.
- 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.
- 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.