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This clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Senior Director who can develop and execute on global regulatory strategies for an early-stage Rare Disease program. In this role, you will work closely with cross-functional teams and Health Authorities to advance key programs and ensure regulatory success. 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 pre-clinical 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.
Ten 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. Must be in the office 3-4 days per week.
The budgeted salary range for this position is US$250,000 to $280,000 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 candidates skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.
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