Senior Expert Regulatory Affairs Full Time - Wuppertal, Deutschland - AiCuris GmbH & Co. KG
vor 5 Stunden
Beschreibung
The Powerhouse for Anti-infectives-
Committed to making the difference:
Ready to fight against infectious diseases? Join our team:
The Senior Expert Regulatory Affairs* provides regulatory expertise and strategic guidance, bringing new drugs from research through the clinical development phases 1-3, up to approval.
Specifically, the senior expert develops the regulatory strategy during drug development, being responsible for all regulatory aspects during the clinical trial phases as well as any interactions with regulatory agencies, proposing the best roadmap for the entire development with respect to regulatory agencies and procedural approaches.
The Senior Expert* will guide the team and facilitate authority meetings with respect to document preparation and meeting discussions.Overall, the role will be responsible for the regulatory and submission strategy and interaction with regulatory authorities along all development phases up to approval.
Responsibilities:
- Provide strategic input and guide the development team on the regulatory requirements and most appropriate regulatory pathways and options during development of new drugs
- Planning and oversight of regulatory submissions to FDA, EMA and other health authorities globally (MAA/NDA, CTA/IND, compassionate use, designations like orphan drug, breakthrough, PRIME and others)
- Evaluate documentation on quality, efficacy and safety for regulatory purposes
- Contact, communicate and interact with regulatory authorities
- Preparation and leading of health authority meetings (FDA, EMA, BfArM and others)
- Plan, coordinate and supervise all types of submissions to regulatory agencies for assigned products/projects
- Review summaries or reports from contributing departments, and provide feedback to ensure accurate and complete documents
- Coordinate and guide writing of documents like IMPD, IB or individual documents or modules according to CTD
- Provide regulatory assessments during due diligences
- Regulatory intelligence, provide and train the development team on proposed/current FDA/EMA regulations and guidelines
Your Profile:
- Academic degree in natural sciences; master's degree in Drug Regulatory Affairs preferred
- Overall, 10 years of work experience in the pharmaceutical industry and 5 years of regulatory experience in drug development in the pharmaceutical industry with knowledge of requirements in US and Europe
- Good organizational, communication and intercultural skills
- Continuous striving for innovative thinking and operational excellence
- Capable of adapting to changes creatively, and ability to remain focused in situations with complex issues
- Excellent communication and team work, leading by example, demonstrating company values and fostering an environment of transparent and effective speaking up
- Flexible, scientific working style and willingness for continuous education
- Fluency in English
What we can offer:
-
Unique corporate culture: Work in an innovative and international research and development company, which received the German Innovation Award. The working atmosphere is characterized by diversity, inspiration with flat hierarchies as well as collegiality and a trustful cooperation.
-
Development: Regular and targeted training as well as individual development opportunities.
-
Flexibility: You have flexible working hours, self-determined time management, the opportunity to work mobile and can take advantage of different offers to reconcile work and family life.
-
Company pension scheme
How to apply:
Interested in joining our team?
If you have any questions, please do not hesitate to contact us at
Mehr Jobs von AiCuris GmbH & Co. KG
-
Werkstudent Human Resources
Wuppertal, Deutschland - vor 1 Woche
-
Clinical Trial Assistant
Wuppertal, Deutschland - vor 3 Wochen
-
Junior Controller
Wuppertal, Deutschland - vor 1 Woche