Senior Expert Regulatory Affairs (m/f/d)
Senior Expert Regulatory Affairs (m/f/d)
AiCuris Anti-infective Cures AG
Wuppertal, Germany
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 as Senior Expert Regulatory Affairs (m/f/d) in full time/reporting to the Head of Regulatory Affairs and Compliance.
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, Non-Clinical and Clinical Overview and Summaries).
Skills and qualifications
- Bachelor/Life Science degree; master's degree in Drug Regulatory Affairs preferred;
- 5 years of regulatory experience in drug development in the pharmaceutical industry;
- Experience and knowledge of the current requirements in the 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.
How to apply?
Interested in joining our team?
Then apply online using the Apply Now button below.
If you have any questions, please do not hesitate to contact us at +49 (0)202 317 630.
AiCuris Anti-infective Cures AG
Human Resources
Ariane Mlitzko Oliveira
Friedrich-Ebert-Str. 475/Build. 302
42117 Wuppertal, Germany
www.aicuris.com
