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Director Regulatory Affairs (Pharma/Life Science)

AiCuris Anti-infective Cures AG Reference number: 10000-1189219809-S
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Language / Application in: Englisch Wuppertal (North Rine-Westphalia) Working hours: Full-time work Type of employment contract: Open-ended Company size: Between 51 and 500

The Senior Expert Regulatory Affairs will support the development team by bringing products from research through the clinical development phases 1–3. Specifically, the position will supervise the execution of clinical trials and will also be in charge regarding the best road map as well as of contacting relevant regulatory authorities at the right time. In addition, the Senior Expert will facilitate authority meetings and prepare the necessary briefing packages containing a full development strategy. On the whole, the role will be responsible for the interaction with regulatory authorities in all phases including dossier preparation and full regulatory submissions.


Responsibilities
• Provide significant input and guide the development team on regulatory requirements, and develop regulatory strategies during development of new drug products
• Evaluate documentation on Quality, Efficacy, Safety on the basis of existing rules and regulations
• Contact and communicate with authorities
• Provide regulatory assessment during due diligences
• Provide information on proposed/current FDA/EMA regulations and guidelines for assigned products/projects to the team
• Work with consultants related to the development activities

AGENCY INTERACTIONS:
• Responsible for agency contact and interaction
• Prepare and lead the team during preparation and conduct of agency meetings (e.g., FDA, EMA, BfArM)

SUBMISSIONS:
• Plan, coordinate and supervise all types of submissions to regulatory agencies for assigned products/projects
• Facilitate and organize the compilation of applications (IND, NDA, BLA, CTA, MAA) to regulatory agencies for development products; maintain up-to-date knowledge of the data, information and formats required for inclusion in these applications
• Review summaries or reports from contributing departments, and provide comments to assure accurate and complete documents for inclusion in applications
• Coordinate writing of documents like IMPD, IB, DSUR or individual modules of the CTD (Quality Summary, Nonclinical and Clinical Overview and Summaries)


Skills and qualification
• Bachelor/Life Science degree; master's degree in Drug Regulatory Affairs preferred
• 5 years regulatory experience in drug development in the pharmaceutical industry
• Experience and knowledge of the current requirements in US and Europe, Asian agencies as a plus
• Excellent communication, team working and leadership
• Good organizational, communication and intercultural skills
• Flexible, scientific working style and willingness for continuous education
• Fluency in English


What we can offer
• Cooperation in multinational and interdisciplinary teams
• An exciting field of activity in a promising research and development company
• Flexible working hours and self-determined time management
• Flexible combination of on-site work and mobile working
• Regular and targeted further training and individual development opportunities
• Attractive remuneration and company pension scheme
• A wide range of offers in terms of health and reconciling work and family life

Do you have questions about job application and job search? The Federal Employment Agency (BA) will provide you with personal support on all topics relating to working in Germany.

Contact us

Contact details

Questions and applications to: AiCuris Anti-infective Cures GmbH
Contact person: Ms. Daniela Boshoven

E-mail: jobs@aicuris.com
Attach: Geforderte Anlagen: Lebenslauf, Zeugnisse

  • AiCuris Anti-infective Cures AG
  • Friedrich-Ebert-Str.
  • 42117 Wuppertal
  • Telephone: +49 202 317632599

Our job advertisements are always directed at all people capable of working, regardless of age, gender, origin, sexual orientation, disability, religion and ideology, etc. Applicants are exclusively selected based on their qualifications. Errors in the given information and spelling reserved.

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