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Insmed Incorporated · 3 days ago

Sr. Director , Regulatory Affairs, Global Regulatory Lead - Development Strategy

Headquarters, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$222K/yr - $303K/yr

5+ years exp

Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Global Regulatory Lead will be responsible for formulating and implementing global regulatory strategies to enable efficient product development, serving as the primary regulatory contact for the U.S. FDA and overseeing regulatory submissions and communications with global health authorities.

BiotechnologyMedicalPharmaceutical

Growth Opportunities

Responsibilities

Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs

Identify and assess regulatory risks associated with product development and define risk-mitigation strategies

Provide regulatory guidance across functions throughout the R&D process and advise on the US IND and global CTA submission strategies

Direct the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applications

Oversee the organization and preparation of clear, concise, and effective regulatory submissions

Provide oversight for preparation and delivery of materials for regulatory agency meetings

Prepare and deliver high-quality presentations for both internal and external audiences

Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential impact on company programs

Lead effectively in a matrix environment, collaborating with regional regulatory leads and cross-functional teams

Qualification

Regulatory AffairsRegulatory submissionsGlobal regulatory requirementsSubmission writingDrug development processAttention to detailCollaborationPresentation skills

Required

Bachelor's degree in life sciences or a related field required

Minimum of 5 years of experience in Regulatory Affairs, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets)

Strong knowledge of global regulatory requirements and submission formats (eCTD)

Proven experience managing complex regulatory deliverables across product lifecycle stages

Strong submission writing and review skills essential

Significant experience in interactions with FDA, EMA, and other global regulatory agencies

Deep understanding of the drug development process

Highly organized with strong attention to detail, accuracy, clarity, and conciseness

Ability to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter

Preferred

advanced degree (MS, PhD, PharmD) strongly preferred

Experience with orphan drug products is highly preferred

Experience with inhalation products a plus

Benefits

Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)

Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration

401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance

Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities

Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Company

Insmed Incorporated

Insmed is a people-ﬁrst global biopharmaceutical company striving to deliver ﬁrst- and best-in-class therapies to transform the lives of patients facing serious diseases.

Founded in 1988

Bridgewater, New Jersey, USA

1001-5000 employees