We use cookies. Find out more about it here. By continuing to browse this site you are agreeing to our use of cookies.
#alert
Back to search results
New

Director, Global Regulatory Lead

Curium Pharma
111 West Port Plaza Drive (Show on map)
Jul 31, 2026

Director, Global Regulatory Lead
Date:

Jul 31, 2026
Location:


St. Louis, MO, United States, 63146



ABOUT CURIUM

The Group Curiumis the world's largest nuclear medicine company with over 1,2+ B revenues. At Curium, we have a singular focus - to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 15 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. As a fast-growing company in a niche market, Curium is today owned by a private equity fund with LBO financing scheme.

Building on its unique strengths across radiopharmaceutical product manufacturing, logistics and commercialization, and led by an agile, LBO-driven leadership team, Curium has already achieved a critical mass and is the largest player in the nuclear medicines field. This is one that has become increasingly dynamic and innovative in recent years.

Summary of Position

The Director, Global Regulatory Lead (GRL) will provide global regulatory leadership for one or more oncology programs focused on radiopharmaceutical/nuclear medicine therapeutics. This individual will develop and execute innovative global regulatory strategies supporting products from early clinical development through registration and lifecycle management.


The successful candidate will serve as the Global Regulatory Lead for multidisciplinary development teams, partnering closely with Clinical Development, CMC, Nonclinical, Medical, Biostatistics, Quality, Biometrics, and Commercial to accelerate development while ensuring compliance with global regulatory requirements.


The ideal candidate possesses extensive experience across both early- and late-stage drug development, including IND/CTA strategy, global Health Authority interactions, registration planning, and lifecycle management for oncology products. Experience with radiopharmaceuticals is strongly preferred.

Essential Functions

Primary Responsibilities



Global Regulatory Strategy




  • Lead development and execution of global regulatory strategies for oncology programs.
  • Serve as Global Regulatory Lead on cross-functional program teams. Develop comprehensive regulatory strategy and provide inputs to integrated program plans.
  • Lead Global Regulatory Team and submission team accountable for delivering global program milestones.
  • Develop regulatory pathways supporting development and commercialization.
  • Identify regulatory risks and opportunities and recommend mitigation strategies.
  • Lead meetings with health authorities, prepare briefing documents and lead cross-functional preparation for agency interactions.
  • Ensure alignment of global regulatory strategy across US, EU, UK, Canada, Australia, Japan, and other key markets.
  • Oversee the preparation and review of global regulatory submissions, including IND, CTAs, IND amendments, Annual reports, NDA/ BLA, etc.
  • Monitor regulatory intelligence and Translate regulatory intelligence into actionable development strategies.

Requirements

Education




  • PhD, PharmD, MD, MS, or equivalent scientific degree preferred
  • Bachelor's degree in life sciences required



Experience required




  • 10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry in oncology drug development
  • Demonstrated experience as global regulatory lead, leading global regulatory strategy as part of cross functional program team
  • Experience spanning early clinical through product registration
  • Experience leading FDA and international Health Authority interactions
  • Experience leading major global regulatory submissions



Preferred:




  • Radiopharmaceutical or nuclear medicine therapeutic experience
  • Targeted radionuclide therapy experience
  • Companion diagnostic experience
  • Combination product experience



Ideal Candidate Profile



The ideal candidate combines deep regulatory expertise with oncology development experience and has successfully led programs from IND/CTA through NDA/BLA or MAA approval. They are comfortable navigating the unique scientific and regulatory challenges associated with targeted radiopharmaceuticals, including dosimetry, isotope manufacturing, companion diagnostics, and accelerated development pathways. They are recognized as a strategic partner capable of influencing senior leadership while effectively collaborating across global, multidisciplinary teams.

Competencies
ANALYZE + ADAPT
COMMUNICATE EFFECTIVELY
DEVELOP SELF + OTHERS
INTERNAL/EXTERNAL CUSTOMER-FOCUSED
RESULTS-DRIVEN


About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.


Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

We believe diversity includes disability, and we actively encourage applications from people with disabilities. If you require any accommodations during the recruitment process, please let us know-we are happy to support you.




Job Segment:
Biology, Biotech, Oncology, Medical Technologist, Compliance, Healthcare, Science, Legal

Applied = 0

(web-77cf7d65c7-rcc7h)