Global Lead Regulatory Affairs (m/w/d)

in full time/ unlimited contract/ reporting to the Head of Regulatory Affairs and Compliance

Global Lead Regulatory Affairs (m/w/d)

in full time/ unlimited contract/ reporting to the Head of Regulatory Affairs and Compliance

The Powerhouse for Anti-infectives–
Committed to making the difference

AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “blockbuster” potential to the market (Prevymis® 2017/18).

Ready to fight against infectious diseases? Join our team!

At AiCuris, Regulatory Affairs and Compliance is of highest importance. Bringing broad knowledge to the regulatory function, you are embedded into AiCuris project teams and support drug development activities up to approval regarding all aspects of regulatory affairs.

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 (eg, 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)

Your Profile

  • Bachelor's degree in Life Science; master's degree in Drug Regulatory Affairs preferred
  • 5-10 years regulatory experience in drug development in the pharmaceutical industry covering (early and) late-stage projects up to approval
  • Experience in and knowledge of the current requirements in the US and Europe; Asian agencies are a plus
  • Excellent communication, team working and leadership
  • Good organizational and intercultural skills
  • Flexible, scientific working style and willingness for continuous education
  • Fluency in English

What we can offer

We 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 company pension scheme
  • A wide range of offers in terms of health care and work-life balance

How to apply

You can find a PDF of the job description opposite.

 

Interested in joining our team?

Then apply online!

If you have any questions, please do not hesitate to contact us at +49 (0)202 317 630.

AiCuris AG
Human Resources
Anna Frey
Friedrich-Ebert-Str. 475 / Build. 302
42117 Wuppertal
Germany
www.aicuris.com