Senior Director, Regulatory Affairs CMC – Gene Therapy

Job not on LinkedIn

🕒 October 14

🇺🇸 United States – Remote

💵 $222k - $303k / year

⏰ Full Time

🟠 Senior

😶‍🌫️ Therapist

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

INSMED

WebsiteLinkedInAll Job Openings

2 - 10 employees

🏥 Healthcare

💼 Consulting

🤝 B2B

Healthcare • Consulting • B2B

INSMED is a Catanduva (SP), Brazil–based occupational health clinic and services provider that helps companies stay compliant with workplace health and safety laws. It offers occupational medicine (admission, demissional, periodic and return-to-work exams), clinical and diagnostic tests (audiometry, spirometry, ECG/EEG, X‑ray, laboratory tests), engineering and safety-of-work services, PGR/risk management, psychossocial risk assessments, mandatory trainings and in‑company exams. INSMED also provides eSocial/SST event management and documentation support for HR and operations, emphasizing fast, in‑person service and compliance for local industry and agribusiness clients.

📋 Description

• Serve as regulatory lead at the CMC sub-team level and ad hoc member of the Global Program Team • Define, develop, and implement global regulatory CMC strategy from early- and late-stage development through registration and lifecycle management • Participate in cross-functional decision-making regarding regulatory impact on CMC quality development and lifecycle management • Identify and communicate CMC risks and implement mitigation strategies • Lead CMC regulatory strategy and prepare key regulatory dossiers, including meeting requests, briefing documents, INDs, CTAs/CTRs, and CTNs • Ensure high-quality, compliant, on-time submissions and application maintenance, including IND/CTA/CTR, IMPD updates, and information amendments • Analyze and apply regulatory guidance and requirements from FDA, EMA, PMDA, and ICH • Monitor regulatory and competitive landscapes and help shape the regulatory environment through comments on draft guidance • Contribute to scientific discussions and collaborations to resolve CMC regulatory issues • Review CMC technical documentation and assess manufacturing, analytical method, raw material, and facility changes for compliance • Guide or lead complex CMC-focused interactions with regulatory authorities and Health Agencies, including FDA • Participate in Global Regulatory Team meetings and serve as regulatory representative on the specification sub-team • Archive correspondence and submissions, manage vendors/consultants, and mentor junior regulatory professionals • Report to the VP, Regulatory Affairs Neuro/Other Rare

🎯 Requirements

• Bachelor’s degree in a scientific discipline • 10+ years’ experience in Global CMC Regulatory Affairs and/or relevant product development experience in the pharmaceutical or biotechnology industry • Minimum of 5+ years of gene therapy orphan (rare) drug development experience • Solid understanding of US, EU, and Japanese regulations for biologics, including gene therapy • Strong working knowledge and direct application of relevant ICH quality/CMC guidance, particularly guidance pertaining to gene therapy product development • Experience submitting and managing quality aspects of IND/CTA/CTR/IMPDs and global registration applications, including BLA, J-NDA, and MAA • Working knowledge of and experience with electronic submissions (eCTD) • Experience leading direct interactions with Health Authorities at key milestone meetings and on complex regulatory matters • Demonstrated leadership of global CMC regulatory strategy for gene therapies across early development, registration, and post-approval lifecycle management • Experience serving as Global CMC regulatory lead on a multifunctional, cross-functional development team • Ability to assess CMC regulatory risk, influence strategic decisions, and exercise sound regulatory judgment on novel or ambiguous issues • Experience partnering with Global and Regional Regulatory leads • Strong cross-functional collaboration and communication skills • Ability to manage multiple priorities, plan, organize, attend to detail, and meet tight deadlines • High initiative, flexibility, sound judgment, independent problem-solving, and high ethical and compliance standards

🏖️ Benefits

• Comprehensive medical, dental, and vision coverage and mental health support • Annual wellbeing reimbursement • Employee Assistance Program (EAP) • Generous paid time off policies • Fertility and family-forming benefits • Caregiver support • Flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match • Annual equity awards • Employee Stock Purchase Plan (ESPP) • Company-paid life and disability insurance • LinkedIn Learning • Skill building workshops • Leadership programs • Mentorship connections • Networking opportunities • Employee resource groups • Service and recognition programs • Opportunities to connect, volunteer, and give back • Occasional domestic and/or international travel for team meetings or events

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume