Project Manager Regulatory CMC (m/f/d)
(20 hours part time)
RD&C Research, Development & Consulting GmbH is a privately owned company founded in March 2014 as an expert office for pharmacy providing specific in-depth expertise for pharmaceutical and biotech projects.
RD&C is certified Consulting engineers for Pharmacy (“Ingenieurbüro für Pharmazie”) in Austria offering in-depth expertise on drug development projects. We are providing project management, consultancy in drug discovery and development projects, support for regulatory topics including a compliant documentation (IMPD, IND, CTD, ERA, Expert Reports, etc.). A specific focus lies on CMC, impurity and degradation profiling and trouble shooting for regulatory issues.
Role and Responsibilities:
- Project management of current and future customer projects (without staff responsibility)
- Contact to and support of our international clients
- Define, manage and coordinate projects in collaboration with internal and external experts and CROs/CMOs
- Topics: CMC, stability, impurities and degradation, regulatory support
- Design and planning of supportive experiments; interpretation of results
- Research on scientific and regulatory topics (scientific literature, patents, guidelines)
- Compilation of regulatory compliant documents including risk assessments
- Support for internal R&D and development projects on stability and degradation
Personal skills and professional experience:
- Master’s degree in Life Sciences, Pharmacy or Medical Sciences preferred and 2-5 years of experience in CMC-management (PhD preferred)
- Comprehensive knowledge of current pharmaceutical industrial standards and guidelines (ICH, EMA, FDA, etc.)
- Experience in project management
- Scientific background is an advantage
- Excellent computer, presentation and communication skills – very good verbally and written English
- Highly reliable with accurate operating principles
- Analytic and systematic approach with good problem-solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
- Team spirit and ability to work and communicate effectively in our team
- Fluency in German and English would be an advantage
We support our employees in achieving a work-life balance and promote the professional equality of women and men. We strive to assist women in their scientific career, increase the number of women in research and reduce under-representation in all areas and positions in general.
Interested in joining our team? Then apply with a motivational letter and CV by contacting our CEO Dr. Norbert Handler.
Dr. Norbert Handler, CEO
RD&C Research, Development & Consulting GmbH
Ebendorferstrasse 10/3, 1010 Wien