This small, clinical-stage biopharma company is developing multiple therapeutic products to treat a range of rare diseases. They are seeking a Regulatory Affairs Senior Director or Executive Director who can develop and implement global regulatory strategies for their portfolio of programs. Reporting into the COO, you will manage assets through all phases of development and work closely with Health Authorities. This is the first FTE Regulatory hire for this organization. This company offers an innovative pipeline, a collaborative company culture, and the ability to work remotely. With their lead candidate currently in Phase 3 trials, now is an exciting time to join this organization!
Responsibilities:
- Ensure the development and execution of regulatory strategies for a portfolio of rare disease programs across all phases of development.
- Balance strategy with execution in a hands-on Regulatory role.
- Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings.
- Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors as needed.
- Play a core role in developing global regulatory strategies for drug development programs, including clinical and pre-clinical stage programs.
- Coordinate and manage regulatory submissions (e.g. INDs, CTAs, NDAs, etc.) in collaboration with senior management and consultants.
- Contribute to the creation of the overall product development strategy and manage the development, monitoring, and delivery of Regulatory project plans throughout the life cycle.
- Provide input on development plans, Target Product Profile (TPP) development, risk assessments, resource planning, and other documents as required.
- Lead regulatory meeting preparation efforts.
- Ensure on-time, high-quality and regulatory–compliant submissions.
- Liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions.
- Prepare, plan and implement new processes and policies to improve efficiency of the company.
Qualifications:
- Bachelor degree required. Advanced degree (MS, PharmD or PhD) preferred.
- 12+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs roles.
- Regulatory experience with Rare Disease programs required.
- Must have drug development experience in the US, EU and UK. Experience in other parts of the world is a plus.
- Experience directly interfacing with health authorities in major markets (FDA, EMA, MHRA) is a must.
- Regulatory experience in multiple phases of development is required.
- Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.
- Must have experience filing major marketing applications (NDAs, MAAs, BLAs, etc.)
- Some CMC Regulatory background desired.
- Strong business acumen and strategic thinking capabilities, able to navigate complex challenges and contribute to the business’s long-term vision.
- Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.
- Excellent communication skills, with the ability to articulate complex issues clearly and persuasively.
- Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.
This is a remote position but candidates on the East Coast are preferred. Some occasional travel will be required.
The budgeted salary range for this position is US$250,000 to $300,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.