Director Regulatory Affairs
My client is a clinical-stage oncology-focused company that is pioneering recombinant antibody mixtures for therapeutic use. We have been retained to fill a newly created Director Regulatory Affairs position that has been created through innovation and growth. In this highly visible role you will be responsible for developing and implementing regulatory strategy while partnering closely with executive management. This is a great opportunity for you to join a growing, collaborative science driven global organization!
Responsibilities:
- Development, (timely) submission and maintenance of clinical trial applications (CTAs/INDs) (and marketing) authorizations to the authorities world-wide
- Ensure timely submission (electronic or paper) of regulatory documents e.g. CTAs/INDs, MAAs, BLAs directly or through a partner (e.g. CRO)
- Design relevant regulatory strategies for targets and product candidates (product development plans)
- Interaction and negotiation of regulatory requirements with any regulatory authority directly or through an established agent.
- Keep executive leadership informed on current FDA and EMEA guidelines or other (inter) national guidelines pertaining to Regulatory Affairs
Knowledge and Skills:
- Minimum BA/BS in a scientific discipline with at least 10 years of total regulatory experience, Advanced degree highly preferred
- Knowledge of FDA and EMA regulations is essential
- Experience with IND and CTA applications
- Experience with biological products
- Strong communication and language skills, written and verbal (English)
- Self-driven, highly motivated, team player with commitment, initiative and humor