This clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director who can develop and execute on global regulatory strategies for a quickly-advancing clinical stage Rare Disease program. In this role, you will work closely with cross-functional teams and Health Authorities to advance key programs and support an upcoming BLA. This company offers innovative science and a collaborative, patient-focused company culture. With their lead programs in Phase 1/2 studies, now is an exciting time to join this growing organization.
Responsibilities:
- Drive global regulatory strategy and operational activities for a Phase 1/2 rare muscular disease program.
- Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc)
- Interact with regulatory colleagues and other departments to develop regulatory strategy and submission plans for quality and timely filings.
- As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
- Oversee preparation, review, and submission of regulatory documents, maintaining compliance with regulatory requirements.
- Manage timelines and preparation of meeting requests and briefing documents.
- Interact with FDA and other regulatory agencies in conjunction with senior Regulatory leaders.
- Author/edit documents to support regulatory submissions.
- Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports
- Prepare for meetings with FDA and other health authorities.
- Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management.
- Contribute to improvements in department best practices and SOPs.
- Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
Qualifications: - Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologic therapeutics.
- Regulatory experience with Rare Disease programs highly desired. Experience with neurology/CNS programs a plus but not required.
- Must have experience working directly with FDA and other Health Authorities (EMA, Health Canada, Japan, etc).
- Experience in designing, writing, and submission of regulatory filings (INDs, CTAs, NDAs/BLAs, ODAs, etc).
- Experience with Accelerated Approvals, Fast Track, and Breakthrough designations a plus.
- Strong understanding of the global pharmaceutical drug development and regulatory environment.
- Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus.
- Must have experience preparing for and participating in Health Authority meetings.
- Excellent oral and written communications skills.
- Strong interpersonal skills, including conflict management and negotiation skills.
- Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
- Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.
This is an onsite position in the Greater Boston area.
The budgeted salary range for this position is US$200,000 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.