The Regulatory Affairs Lead, reporting into the Head of R&D, will take primary responsibility for the development and execution of our regulatory strategy.
The role will involve managing all regulatory aspects of company products, information and activities, with particular emphasis on clinical and nonclinical development activities, and pharmacovigilance.
Responsibilities include (but are not limited to):
- Acting as the point of contact for all interactions with Competent Authorities regarding the development of COMPASS Pathways products
- Ensure a sound regulatory strategy is in place for supporting products through development, in particular for nonclinical and clinical data, and for gaining timely product approval
- Participating in key meetings as necessary to develop and agree regulatory strategy and to provide guidance for the pre-clinical and clinical data necessary for Marketing Authorisation Applications (MAAs), Clinical Trial Authorisations (CTAs), Investigational New Drug (IND) dossiers, New Drug Applications (NDAs), and meetings (such as Scientific Advice, Type A and B FDA meetings and so on)
- Contribute to overall Research and Development (pipeline) projects as a Regulatory lead
- Maintaining oversight over regulatory practices and procedures, including document management and archiving, regarding clinical and non-clinical development activities as they relate to regulatory interactions with Competent Authorities
- Compiling and maintaining CTAs in liaison with our team members, commercial partners and external consultants
- Liaison with external pharmacovigilance team in ensuring safety-related documentation is maintained
- Maintaining cGXP and H&S knowledge applicable to the job
If interested, please send your CV and statement of interest to firstname.lastname@example.org.
|Job Category||Biotech, Pharmaceuticals|
|Role||Regulatory Affairs Lead|