Job Details
Posted 18 August, 2026
Job Id: 629682
Sr Director, Regulatory Affairs
Job Description
Intake call with HM scheduled for tomorrow at 1pm est.
Location: REMOTE EST
Salary: Market
| Job Title / Position: | Director/Senior Director Regulatory Affairs |
| Department: | Regulatory Affairs |
| Line Manager / Supervisor Job Title / Position: | Ellery Mangas |
Purpose of Job
- The Director/Senior Director of Regulatory Affairs will report to the Vice President of Regulatory Affairs and serve as a global liaison to regulatory authorities for gene therapy products
Major Activities and Responsibilities
- Develop and implement global regulatory strategies that support efficient development and registration of gene therapy products.
- Work proactively in a cross-functional organization to help execute effective regulatory strategies in alignment with nonclinical, CMC and clinical development plans and portfolio strategy
- Lead the preparation, review, and submission of regulatory applications including: INDs/CTAs and amendments, BLAs/MAAs and supplements, Annual Reports, PIPs/PSPs and specialty designation applications (e.g., Fast Track, RMAT, PRIME, ILAP)
- Prepare for and lead negotiations with FDA, EMA, MHRA and other health agencies. This includes, preparing responses to questions and inquiries from health authorities, overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.
- Independently manage projects and execute as the RA lead, both in an operational and technical role
- Review critical regulatory communications and evaluate conformance with regulatory requirements, clarity, and completeness
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
- Work with Regulatory CMC and Regulatory Operations to prepare, produce and submit health authority documents using internal and external resources
- Manage contracted third party providers
Key Performance Indicators
- Achievement of product development milestones
- Maintenance of compliance with product reporting requirements
Key Job Competencies
- Excellent organizational, communication and time management skills
- Thorough knowledge of the drug research, development, and commercialization processes
- Cross-functional leadership
- Strategic planning and Execution
- Stakeholder communication and influencing
- External partner management
- Ability to set and achieve challenging goals, demonstrate persistence and overcome obstacles and measure self against standard of excellence
- Speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings
- Writes clearly and informatively; edits work for spelling, grammar and formatting; varies writing style to meet needs; able to read and interpret written information
- Sensitivity and experience with non-domestic organizations/cross-cultural environments
Qualifications
- Bachelor’s degree in scientific discipline with 10+ years of pharmaceutical industry experience, predominantly in Regulatory Affairs
- Master’s degree, PharmD, or PhD preferred
- RAPs certification preferred, but not required
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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