Regulatory Strategy Director

Our client is developing small molecule precision medicines for the treatment of neurological and psychiatric disorders. They are seeking a Regulatory Strategy Director who can develop and implement regulatory strategies for a late-stage program. Reporting into the VP of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with Health Authorities. This company offers a strong development pipeline, innovative science, and excellent funding. With two programs going into Phase 3 global trials, now is an exciting time to join this growing organization! Responsibilities: Create and implement innovative and effective regulatory strategies to support the development of global drug development programs, including a Phase 3 epilepsy program. Provide regulatory expertise and advice to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical. Serve as the regulatory lead on project teams. Represent the company as the point of contact for FDA and other regulatory health authorities. Maintenance of regulatory applications such as INDs, CTAs, NDAs, etc. Identify regulatory risks and mitigation plans. Ensure compliance with local and international submission requirements. Manage CROs as applicable. Ensure exemplary ethics and transparency within the company and with health authorities. Keep current with global regulatory landscape and advise project teams on potential impact to programs Provide mentorship and support to junior team members to foster their professional growth and development. Qualifications: Bachelor degree in life sciences required. Advanced degree such as MS, PhD, or Pharm D preferred. 12 or more years of experience in the pharmaceutical or biotech industry with 10+ years in clinical Regulatory Affairs. Experience with neurology/CNS programs and small molecules preferred, but not required. Must be able to develop regulatory strategies and also do more tactical hands-on execution. Late-stage/Phase 3 experience highly desired. Experience working with DAAP or Neurology FDA Divisions is desired, but not required. Must have Global drug development experience including EU/EMA. Experience working on a major marketing application (NDA/BLA/MAA) a plus. Ability to manage competing priorities, influence and integrate within a team, manage timelines and deliver on corporate and program goals. Strong interpersonal skills and alignment with the company’s values and company culture Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving. Thorough understanding of the development phases within a fast-moving biopharmaceutical organization. Exceptional written and verbal communication skills. Must be flexible and comfortable with ambiguity in a fast-paced, small company environment. NOTE: This hybrid role is based in Boston MA and the Regulatory Strategy Director must be onsite in the office three days a week. The budgeted salary range for this position is $220,000 to $240,000 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.