Director - Global Regulatory Lead

10+ years

Not Disclosed

Remote, USA

10 Nov. 11, 2024

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 Leader

Location: Lexington, MA or Plainsboro, NJ
Department: East Coast Global Development Hub

Are you a global regulatory expert with a passion for innovative medicines?

Join Novo Nordisk as a Global Regulatory Leader where you will play a key role in shaping and executing regulatory strategies for high-impact projects. You will lead a global regulatory team in developing and advancing investigational medicines through the clinical development process, working with cross-functional teams and regulatory authorities to deliver life-changing treatments. If you are motivated by science and making a meaningful impact, this opportunity is for you!

The Position

As a Global Regulatory Leader, you will lead the development and execution of regulatory strategies for Novo Nordisk’s investigational medicines. Your role will involve strategic decision-making, health authority interactions, and driving global filings and submissions. You will oversee the global regulatory team, ensuring the timely and high-quality delivery of regulatory milestones and working in close collaboration with internal stakeholders and external regulatory agencies.

Key responsibilities include:

Global Regulatory Strategy: Lead the development and execution of regulatory strategies for assigned programs, ensuring alignment with development goals and regulatory requirements.
Health Authority Interactions: Manage interactions with regulatory authorities, preparing briefing materials, and leading meetings with agencies like the FDA and international counterparts.
Global Filing and Submission Support: Lead and support regulatory submissions, ensuring that all clinical, nonclinical, and submission-related documents meet regulatory standards.
Risk Management: Communicate regulatory risks and mitigation strategies to management and stakeholders, ensuring a proactive approach to addressing potential challenges.
Team Leadership: Lead and mentor the Global Regulatory Matrixed Team, ensuring that development activities are aligned with business priorities.
Competitive and Regulatory Landscape Analysis: Research and analyze evolving global regulatory landscapes to ensure the development of forward-thinking regulatory strategies.
Documentation and Review: Supervise the regulatory review of clinical and nonclinical documents, including study protocols, reports, investigator brochures, and application summaries.

Qualifications

To succeed in this role, you should have:

Bachelor’s degree in a scientific discipline (advanced degree strongly preferred).
Minimum of 10 years of experience in drug development and regulatory affairs, with a deep understanding of global regulatory requirements for drugs and biologics.
Proven track record of developing regulatory strategies and leading regulatory teams.
Strong experience in regulatory authority interactions, including leading meetings with agencies like the FDA.
Experience in rare disease drug development, innovative trial design, or expedited regulatory pathways is highly desired.
Strong verbal and written communication skills, with the ability to clearly articulate regulatory strategies and risks.
Ability to thrive in a dynamic, fast-paced environment, and manage multiple priorities across different time zones and cultures.
Leadership: Proven ability to lead and motivate teams toward achieving joint objectives and business goals.

About the Department

The East Coast Global Development Hub at Novo Nordisk brings together world-class expertise in life sciences and cutting-edge research to advance our mission of improving patient outcomes. With state-of-the-art facilities in Lexington, MA, and Plainsboro, NJ, the hub supports projects from early research through late-stage clinical development. By blending the speed and agility of biotech with the resources and stability of a large pharmaceutical company, the hub is positioned to drive innovation in multiple therapeutic areas.

Working at Novo Nordisk

At Novo Nordisk, we are driven by a singular purpose: to change the lives of patients by delivering life-changing treatments. Our inclusive culture values diversity and promotes collaboration across teams and geographies. We believe in empowering employees to achieve their full potential, offering opportunities for personal and professional growth. Join us in making a meaningful impact on global health.

How to Apply

If you’re ready to take on this exciting opportunity, please apply by submitting your CV and including a brief statement on why you are interested in the position. Cover letters are not required, and we kindly ask that you do not include a photo in your CV for a fair and efficient recruitment process.

Deadline

Applications will be reviewed on an ongoing basis.

Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer. We embrace diversity and encourage applicants from all backgrounds to apply. All qualified applicants will be considered for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Contact

For assistance or accommodations during the application process, please contact us at 1-855-411-5290. This number is for accommodation requests only.

Latest Jobs

Pharma Jobs in India

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

Director - Global Regulatory Lead

Job Description

Job Title: Global Regulatory Leader

Are you a global regulatory expert with a passion for innovative medicines?

The Position

Qualifications

About the Department

Working at Novo Nordisk

How to Apply

Deadline

Equal Opportunity Employer

Contact

Latest Jobs

Manager, Cmc

Regulatory Affairs Department Assistant(Contractor)

Senior Scientist, Protein Chemistry

Medical Science Liaison

​​Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences​

Associate Central Monitor, Data Surveillance, Clinical Data Sciences

Clinical Research Associate

Project Manager

Biostatistician

Database (Programming) Analyst (Associate), Clinical Data Management

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences