Global Regulatory Affairs Lead – Strategy & Submissions

Regulatory Jobs; Cambridge (MA); On-site; USD 100,000 - 143,000; Full time

Job summary

Relay Therapeutics is seeking a motivated regulatory professional to join our growing team. You will support the development and execution of regulatory strategies to advance our transformative pipeline and collaborate with cross-functional teams to deliver domestic and international submissions including IND, CTA, NDA/MAA.

You will coordinate preparation of high-quality submission documents, assist in meetings with health authorities, and monitor regulatory intelligence to mitigate risks.

Qualifications

• 2+ years of regulatory experience in drug development.
• Familiarity with global regulatory submissions (IND, CTA, NDA/MAA).
• Experience collaborating with R&D, clinical, and QA teams.

Responsibilities

• Support development and execution of regulatory strategies for programs from FIH to late-stage.
• Coordinate preparation and submission of regulatory documents (IND/CTA/NDA/MAA) worldwide.
• Assist in meetings with health authorities and prepare briefing packages.
• Monitor regulatory intelligence and update program strategies accordingly.
• Assist in pursuing regulatory designations and CDx strategy development.
• Oversee regulatory activities performed by CROs and vendors.

Skills

Regulatory submissions

IND/CTA/NDA/MAA experience

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree or higher in a scientific field

Job description

Relay Therapeutics is seeking a motivated regulatory professional to join our growing team. You will support the development and execution of regulatory strategies to advance our transformative pipeline and collaborate with cross-functional teams to deliver domestic and international submissions including IND, CTA, NDA/MAA.

You will coordinate preparation of high-quality submission documents, assist in meetings with health authorities, and monitor regulatory intelligence to mitigate risks.