This biotech startup uses a proprietary platform that enables the discovery and development of potential therapies for a broad spectrum of diseases. They are seeking a Senior Director/Head of Regulatory Affairs who can develop and lead regulatory strategies for all aspects of their early-stage rare diease programs (pre-clinical, clinical, and CMC). Reporting to the CMO, you will establish the Regulatory function for the organization while advancing the company’s programs. This company offers great science, a transparent and fun company culture, and unlimited paid time off! Now is an ideal time to join this growing organization and make an impact on patients in need.
- Develop and lead regulatory strategies for a portfolio of early-stage programs.
- Manage the planning, preparation, submission, and maintenance of INDs, IMPDs, NDAs, BLAs, MAAs, Orphan Drug Applications, Pediatric Investigational Plans, and other regulatory submissions as appropriate.
- Lead Regulatory sub-teams by providing strategic guidance across the different clinical programs to write, critically review, and ultimately obtain Health Authority approvals.
- Function as the primary liaison with FDA and other regulatory agencies.
- Continually monitor newly published FDA guidelines and international guidance documents with respect to our multiple current and future development programs.
- Provide training on applicable requirements for scientific & clinical staff as required
- Manage external Regulatory services vendors (publishing, CMC, etc.)
- Serve as a subject matter expert on Regulatory Affairs processes.
- Advise program leaders with relevant expertise where needed.
- Review and edit technical documents provided by the clinical, clinical pharmacology and nonclinical functions and extract information necessary for regulatory submissions.
- Establish regulatory SOPs and develop regulatory budgets.
- Ensure adherence to relevant regulatory guidance and regulations.
- Bachelor degree required. Advanced degree, such as PharmD, PhD, MS preferred.
- Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Regulatory experience with rare disease programs is required.
- Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, and/or MAAs.
- Direct experience in initiating and conducting successful interactions within FDA or other Health Authorities.
- Experience with Orphan Drug Applications, Fast Track Designations, and/or Breakthrough Designations desired.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, and regulatory responses.
- Strong global experience and knowledge of US and global regulatory requirements and guidelines for US FDA, EU EMA, and other global health authorities.
- Must be collegial, collaborative and open to feedback from others across the organization.
- Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner.
- Must be flexible and comfortable with ambiguity in a small company environment.
- A self-starter who thrives in a dynamic & fast-paced organization and who is ready to embrace the challenge of establishing a Regulatory department from the ground up.