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! This role is remote with some regular travel. Now is an ideal time to join this growing organization and make an impact on patients in need.
Responsibilities:
- 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.
Qualifications:
- 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.