Sr Global Program Regulatory Manager (Associate Director level) Cardio-Renal-Metabolic

Legend Biotech USA; East Hanover (NJ); On-site; USD 145,000 - 271,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to lead product registration and submission processes. This role involves strategic direction and collaboration with cross-functional teams to ensure timely approvals of drugs and biologics. The ideal candidate will have a strong background in regulatory submissions and a science-based degree. Join a passionate community dedicated to improving lives through innovative solutions. This opportunity offers competitive compensation and a chance to make a significant impact in the pharmaceutical industry.

Qualifications

• 4-6 years of experience in regulatory drug/biologic development.
• Strong knowledge of regulatory submission processes.

Responsibilities

• Implement regulatory strategies across major regions.
• Drive the coordination and submission of dossiers worldwide.
• Prepare responses to Health Authority requests.

Skills

Regulatory submission processes

Cross-functional team collaboration

Regulatory strategy development

Health Authority negotiations

Data analysis (efficacy and safety)

Education

BS or MS in a science-related field

MD, PhD, or PharmD (preferred)

Job description

Job Description Summary
Directs the development and submission of product registration documents, progress reports, supplements, amendments, and periodic experience reports. Provides strategic product direction to teams, interacts and negotiates evidence with regulatory agencies, and serves as a regulatory liaison throughout the product lifecycle. Ensures rapid and timely approval of new drugs, biologics, biotechnology products, and medical devices, maintaining continued approval status of marketed products. Acts as a regulatory representative to marketing or research teams and government agencies, advising on manufacturing changes, line extensions, technical labeling, and regulatory interpretations. Coordinates, reviews, and may prepare reports for submission.

Key Responsibilities:

• Implement regulatory strategies and manage operational activities across major regions.
• Contribute to global regulatory strategies and identify gaps or risks in strategic plans.
• Align with regions on regulatory strategies to meet business objectives and implement plans accordingly.
• Determine requirements and set objectives for interactions with Health Authorities (HAs).
• Prepare briefing books, summary documents, and coordinate responses to HA requests.
• Serve as local HA liaison if applicable.
• Drive the coordination, planning, and submission of dossiers worldwide.
• Review, approve, and submit Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

Essential Requirements:

• Science-based BS or MS degree with relevant experience; advanced degrees (MD, PhD, PharmD) preferred.
• Strong knowledge of regulatory submission and approval processes in one or more major regions.
• Experience leading regulatory submissions and approvals in at least one major region.
• Experience working in global/matrix environments and with cross-functional teams in the pharmaceutical industry, including HA negotiations.
• 4-6 years involvement in regulatory drug/biologic development activities from Phases I-IV, including innovation in regulatory strategy and post-marketing strategies.
• Experience in dossier submissions, approvals, and negotiations with HAs.
• Proven ability to analyze efficacy and safety data and possess regulatory operational expertise.

The salary range at the start of employment is expected to be between $145,600 and $270,400 per year. Compensation may include bonuses, stock units, benefits, and other incentives. Final salary depends on various factors, including location, experience, and performance.

Why Novartis: Helping people with disease requires more than science; it requires a passionate community working together to create breakthroughs that improve lives. Learn more at our culture.

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EEO Statement: We are Equal Opportunity Employers and do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or other protected statuses.

Accessibility: We are committed to providing reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone] with your request and job requisition number.