Innovative Biologic submissions – early to late phase
Our client is an R&D driven biotech company based in in Zurich. Own Research and development activities as well as international clinical development cooperations gave rise to an exciting pipeline with promising perspectives. The further growth needs the support of a Sr. International RA Manager with strategic and hands-on experience for new submission of innovative Biologics.
Your Challenges
1. Develop and implement regulatory strategies for biologics drug development
2. Provide strategic regulatory guidance to cross-functional teams (R&D, Clinical and Quality) during drug development stages
3. Manage regulatory submissions (e.g. INDs, CTAs, etc.) including vendor management
4. Serve as the primary point of contact with regulatory agencies (FDA, EMA etc.)
5. Monitor changes in regulatory environments and advise on potential impacts
As a Senior RA Manager you are responsible for proactive and efficient management of all regulatory aspects for the assigned product line and assume a cross-functional leadership role for preclinical, clinical as well as NDA submissions in an innovative therapeutic area. You assure the regulatory compliance of Clinical Development and other functions for assigned compounds subject to regulatory requirements and provide advice and input. You are able to lead HA interactions and liaise as well with vendors and potential partners.
Your Experience
6. Master’s degree in Biology, Neuroscience or related field
7. 5-10 years of regulatory affairs experience in the pharmaceutical or biotech industry
8. Proven experience with regulatory submissions
9. Leadership and influencing skills as well as team collaboration skills
10. Excellent written and verbal communication abilities
Seize an interesting and multifaceted opportunity in a dynamic and international environment which will apply your skills and talents. Make a valuable impact and contribute to the future success of an exciting company undergoing a major corporate development phase.
For the time being the role is defined as part time temporary opportunity for 12 months. There is a high probability that this assignment will subsequently result in a permanent position.
Interested? We are looking forward to get in touch with you.