Project Manager Regulatory CMC (m/f/d)

(20 hours part time)

Our Company:

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

What we can offer:

• Broad and exciting field of activity in a growing consultancy company
• Cooperation with multinational and interdisciplinary teams and clients
• Small team with flat hierarchy
• Flexible working hours and self-determined time management
• Regular and targeted further training and individual development opportunities
• Office in the heart of the city of Vienna
• Flexible and family-friendly working hours, home-office by arrangement
• Opportunities for further education and training
• The minimum salary in Austria for this position is € 2.440,28 gross per month (full time, collective wage agreement for Information and Consulting, use group IV), we offer increased payment according to your expertise.

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.

Contact details:
Dr. Norbert Handler, CEO
RD&C Research, Development & Consulting GmbH
Ebendorferstrasse 10/3, 1010 Wien
office@rdc-concepts.com