Global Regulatory Strategy Director – Oncology

Daiichi Sankyo, Inc.; Basking Ridge (NJ); On-site; USD 193,000 - 290,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Director, Global Regulatory Affairs (GRL) to lead and shape global regulatory strategy for development programs. You will represent Regulatory Affairs in GPT meetings and guide cross-functional teams on strategic regulatory issues, coordinating input from regional strategists for Health Authority interactions.

You will oversee regulatory documents, collaborate with Alliance Partners, and ensure alignment with latest Health Authority guidelines across regions.

Qualifications

• Bachelor's Degree in a scientific discipline required.
• Advanced degree preferred (Masters/PhD/MD/PhD/PharmD).
• 7+ years of pharmaceutical experience with 5+ years in regulatory strategy.

Responsibilities

• Manages, directs, and drives the strategy for all regulatory activities for new and approved products.
• Ensure global regulatory strategy is endorsed by the Global Project Team and governance bodies.
• Lead the Global Regulatory Team with regional strategy integration including CMC, supply chain, and commercialization.
• Serve as primary contact with alliance partners and Joint-GPT.
• Stay current with Health Authority guidelines and advise regulatory and other departments.
• Communicate with outside consultants as needed.

Skills

Regulatory strategy leadership

Global regulatory affairs

NDA/BLA submissions

Health Authority negotiations

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Advanced degree (Masters, Pharm.D., Ph.D., MD, JD)

Job description

Daiichi Sankyo, Inc. is seeking a Director, Global Regulatory Affairs (GRL) to lead and shape global regulatory strategy for development programs. You will represent Regulatory Affairs in GPT meetings and guide cross-functional teams on strategic regulatory issues, coordinating input from regional strategists for Health Authority interactions.

You will oversee regulatory documents, collaborate with Alliance Partners, and ensure alignment with latest Health Authority guidelines across regions.