Director Global Regulatory Affairs

Ritual IT Consulting Inc; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Clientis is seeking a Global Regulatory Lead to own regulatory strategy and execution for an assigned program. You will partner with the program team to minimize reliance on external consultants while driving filings and agency communications.

The role requires extensive experience in IND/CTA submissions and global strategy, with a track record as a primary author for regulatory designations and briefing books. Strong cross-functional leadership is essential for success.

Qualifications

• 8+ years of regulatory experience, including at least 2–3 years at Associate Director level (or 1–2 years at Director level or higher)
• Experience leading global regulatory submission strategy and filing (IND/CTAs) across FDA, EMA, MHRA
• Direct experience crafting meeting packages to support agency interactions
• Direct experience as primary author/strategist for regulatory designations (orphan, fast track, breakthrough)
• Experience with briefing books for health authority interactions
• Flexible, adaptive, independent, capable of driving regulatory processes forward

Responsibilities

• Plan and take the lead on IND/CTA filings
• Develop and execute regulatory strategy to align global study milestones
• Primary author and strategist for regulatory and clinical documents
• Map regulatory pathways for the assigned program, including designations and pediatric plans
• Lead multi-functional workstreams to prepare and lead health authority interactions

Job description

Clientis expanding its regulatory capacity to keep pace with the growing workload across three clinical assets. Reporting to the VP, Regulatory Affairs, the Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing our reliance on costly external consultants and closing the timeline gaps created by competing priorities.

Key Responsibilities

• Plan and take the lead on IND/CTA filings
• Develop and execute regulatory strategy to align global study milestones
• As a primary author and strategist to develop key regulatory and clinical documents
• Map out regulatory pathways for the assigned program, including designations, pediatric plans, and related strategy
• Spearhead multi-functional workstreams to prepare and lead health authority interactions

What Success Looks Like

• In 3 months: Build a strong understanding of the modality and disease science, establish a strong working relationship with the program team, and lead the workstream for authoring regulatory documents
• In 6 months: Perform a regulatory gap analysis and lead the preparation and execution of regulatory filings
• In 12 months: Fully operate as a global regulatory lead, formulating long-term regulatory strategy and identifying opportunities for expedited pathways

Qualifications — Required

• 8+ years of relevant regulatory experience, including at least 2–3 years at the Associate Director level (or 1–2 years at the Director level or higher)
• Experience leading global regulatory submission strategy and filing (IND and/or CTAs) across major health authorities (e.g. FDA, EMA, MHRA)
• Direct experience of crafting meeting package to support agency interactions
• Direct experience as the primary author and strategist for regulatory designations (eg., orphan drug designation, fast track, breakthrough)
• Experience with prior health authority interactions and briefing book authoring
• Flexible and adaptive, open-minded, easy to work with, and able to independently drive the regulatory process forward

Experienced – Preferred

• Experience in cardiac or muscular dystrophy disease areas
• Experience working with siRNA or antisense oligonucleotide (ASO) therapies