Associate Director - Global Regulatory Lead

9+ years

Not Disclosed

Plainsboro

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Regulatory Lead
Location: Plainsboro, United States
Job Category: Regulatory Affairs & Safety Pharmacovigilance

Apply Now

About the Department:

At Novo Nordisk, our East Coast Global Development Hub, located in Lexington, MA and Plainsboro, NJ, brings together top minds in life science innovation. From early research to late-stage clinical development, we support the entire program lifecycle. Our hub is a place where biotech agility and pharmaceutical stability come together, allowing us to develop medicines that can change the lives of patients. We are building a future-focused R&D community driven by collaboration, cutting-edge research, and partnerships across various innovative modalities and therapeutic areas. Are you ready to make a meaningful impact?

The Position:

We are seeking a Global Regulatory Lead who is collaborative, science-driven, and passionate about working on innovative investigational medicines. In this role, you will lead a global regulatory team, developing and executing strategies for high-impact projects while working with key decision-makers across multiple functional areas.

Key Responsibilities:

Regulatory Strategy & Team Leadership:

Serve as a key member of the Global Project Team (GPT), providing guidance on development strategies, regulatory activities, and potential risks.
Lead the Global Regulatory Matrixed Team, defining and executing the regulatory strategy for assigned programs to ensure timely, high-quality regulatory deliverables.
Lead health authority interactions, preparing briefing materials and conducting meeting preparation.
Lead or support global filing activities for submissions, ensuring successful and timely regulatory outcomes.
Present regulatory strategies and mitigation plans to management and internal stakeholders.

Document Review & Research:

Perform regulatory review of clinical and nonclinical documents for submissions, including protocols, study reports, preclinical reports, investigator brochures, and application summary documents.
Continuously research and analyze competitive and regulatory landscapes to maintain up-to-date knowledge of global regulatory requirements.

Stakeholder Communication & Risk Management:

Clearly communicate regulatory risks and mitigation plans, both internally and externally, ensuring alignment on project goals and regulatory deliverables.
Effectively manage timelines and priorities in a dynamic, fast-paced, and culturally diverse environment.

Qualifications:

Education & Experience:

Bachelor’s degree required, with an advanced degree preferred.
8+ years of experience in the pharmaceutical/related industry, specifically in drug development.
Proven expertise in global regulatory requirements for drugs and biologics.
Demonstrated ability to develop robust regulatory strategies.
Experience leading meetings and interacting with regulatory authorities, particularly the FDA.
Experience in rare disease drug development, innovative trial design, and/or expedited regulatory pathways is highly desirable.

Skills & Competencies:

Strong leadership skills, including experience setting direction for and motivating teams towards joint objectives.
Excellent verbal and written communication skills, with the ability to communicate complex regulatory information effectively.
Strong organizational and problem-solving abilities, with a track record of thriving in a high-pressure environment.

Why Join Novo Nordisk:

At Novo Nordisk, we’re committed to creating a culture that celebrates diversity and inclusion. We value employees with diverse perspectives, backgrounds, and cultures, believing that it leads to better outcomes for the patients we serve. If you're ready to be part of a team that’s making a life-changing difference for patients, we want to hear from you.

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Associate Director - Global Regulatory Lead

Job Description

Apply Now

About the Department:

The Position:

Key Responsibilities:

Regulatory Strategy & Team Leadership:

Document Review & Research:

Stakeholder Communication & Risk Management:

Qualifications:

Education & Experience:

Skills & Competencies:

Why Join Novo Nordisk:

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