Director Global Regulatory Affairs

ClinLab Solutions Group; Watertown (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

ClinLab Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing reliance on external consultants and closing timeline gaps created by competing priorities.

Responsibilities include planning IND/CTA filings, developing global regulatory strategies, authoring regulatory and clinical documents, mapping pathways and managing health authority interactions to drive

Qualifications

• 8+ years of regulatory experience with progression to senior level.
• Leadership in global IND/CTA submission strategy across FDA/EMA/MHRA.
• Experience crafting meeting packages for agency interactions.
• Primary author for regulatory designations (e.g., orphan, fast track).
• Experience with health authority briefing book authoring.
• Ability to drive regulatory processes independently and collaboratively.

Responsibilities

• Plan and lead IND/CTA filings for assigned programs.
• Develop and execute regulatory strategy to align global milestones.
• Primary author and strategist for regulatory and clinical documents.
• Map regulatory pathways including designations and pediatric plans.
• Lead multi-function workstreams to prepare health authority interactions.

Skills

Regulatory strategy

Global submissions

Health authority engagement

Regulatory documentation

Leadership

Cross-functional collaboration

Job description

We are expanding our 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