Associate Director - Global Regulatory Lead

Novo Nordisk

10+ years

Not Disclosed

Plainsboro

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 Lead – East Coast Global Development Hub

Location: Lexington, MA / Plainsboro, NJ
Department: Global Regulatory Affairs

About the Department

Our East Coast Global Development Hub unites the best minds in life science innovation across our facilities in Lexington, MA and Plainsboro, NJ. We are at the forefront of developing new medicines, supporting projects from early research through late-stage clinical development. Our unique approach combines the speed and agility of biotech with the resources and stability of a large pharmaceutical company, creating an R&D community where collaboration and cutting-edge research thrive. We’re committed to improving human health, and we need passionate individuals like you to help us change lives. Ready to make a difference?

The Position

We are seeking a collaborative, science-driven Global Regulatory Lead to guide regulatory strategies for high-impact, innovative investigational medicines. In this role, you will lead a global regulatory team to ensure the timely and effective execution of regulatory activities across multiple functional areas, while also engaging with health authorities and internal stakeholders to achieve development goals.

Key Responsibilities

Global Regulatory Leadership: Serve as a key member of the Global Project Team (GPT), utilizing industry knowledge to develop innovative regulatory strategies and approaches.
Strategic Planning: Lead the Global Regulatory Matrixed Team to define and execute regulatory strategies for assigned programs, ensuring high-quality deliverables.
Health Authority Interactions: Lead health authority interactions, including the preparation of briefing materials and coordination of meetings with regulatory agencies such as the FDA.
Global Filing Support: Lead and support global filing activities and regulatory submissions for investigational medicines.
Regulatory Risk Management: Present regulatory strategies, risks, and mitigation plans to management and internal stakeholders, ensuring alignment with overall development goals.
Document Review: Oversee regulatory review of clinical and non-clinical documents (clinical protocols, study reports, preclinical reports, etc.) for submission.
Competitive Landscape Analysis: Continuously monitor and analyze evolving global regulatory requirements, ensuring strategies are adapted accordingly.
Timeline Management: Manage regulatory timelines effectively in a fast-paced, dynamic environment, coordinating work across different time zones and cultures.

Physical Requirements

0-10% overnight travel required.
Ability to lift 0-10 lbs.

Qualifications

Bachelor’s degree required (advanced degree preferred).
Minimum of 8 years in pharmaceutical or related industry experience in drug development.
Demonstrated expertise in global regulatory requirements for both drugs and biologics.
Proven ability to develop robust regulatory strategies and navigate complex regulatory landscapes.
Extensive experience interacting with regulatory authorities on an international scale, including leading meetings with agencies like the FDA.
Experience with rare disease drug development, innovative trial designs, and expedited regulatory pathways is highly desirable.
Strong leadership skills with the ability to set direction, motivate, and guide teams toward shared objectives.
Excellent verbal and written communication skills.
Exceptional organizational, problem-solving, and time management capabilities.
Ability to remain positive and thrive in a fast-paced environment under pressure.

Working at Novo Nordisk

At Novo Nordisk, we are driven by our mission to improve patient outcomes worldwide. Our global team of over 63,000 employees collaborates across functions and geographies to develop innovative treatments for chronic conditions. Together, we work toward one common goal: to change lives for the better. We value diversity, continuous development, and the unique skills each individual brings to the table. Novo Nordisk is committed to making a real difference in healthcare—are you ready to join us?

Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer, committed to fostering an inclusive culture that celebrates diversity in the workplace. We encourage candidates from all backgrounds to apply, regardless of race, ethnicity, gender, sexual orientation, disability status, or other protected characteristics.

How to Apply

To apply for this exciting opportunity, please submit your CV and cover letter via the Apply button on the Novo Nordisk website.

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