Senior Director, Regulatory & Scientific Affairs

Senior Director, Regulatory Strategy & Scientific Affairs

Strategic Consulting | Advanced Therapies | Global Role

Shape the future of complex drug development

We are seeking an experienced Senior Director, Regulatory Strategy & Scientific Affairs, to join our growing Strategic Consulting team.

This is a high-impact, client-facing role for a regulatory leader who thrives at the intersection of science, strategy, and innovation and who wants to go beyond traditional regulatory execution to lead complex programs and influence critical development decisions.

You will work directly with biotech and pharma clients to drive and execute regulatory strategy within active programs, particularly in high-complexity settings such as cell and gene therapy (CGT) and other advanced modalities.

What you will do

Lead regulatory strategy for complex programs


* Own and drive global regulatory strategy across:



* CMC (including biologics and advanced therapies)


* Nonclinical development


* Device and combination products

Translate high-level development strategies into clear, actionable, regulator-ready plans

Provide deep scientific and regulatory leadership to guide critical program decisions

Partner with clients to deliver strategic outcomes


* Act as a senior regulatory leader within ongoing engagements, working closely with client stakeholders


* Lead program-level strategic discussions, particularly in complex or high-risk scenarios


* Build strong relationships through delivery excellence and strategic insight, contributing to long-term partnerships

Lead global health authority interactions


* Represent programs in interactions with FDA, EMA, MHRA, and other agencies


* Own the scientific and regulatory narrative presented to health authorities


* Lead preparation of:



* Briefing packages


* IND/CTA and IMPD strategies


* Key regulatory responses and negotiations

Work across disciplines to deliver integrated solutions


* Collaborate with experts in:



* Clinical and Translational Strategy


* Quantitative Strategy (MIDD)


* Medical and Safety teams

Ensure alignment across CMC, nonclinical, and clinical strategy

Translate complex inputs into cohesive development strategies

Support consulting growth and delivery excellence


* Contribute to proposal development and strategic scoping of projects


* Identify opportunities to expand scope within active programs


* Mentor team members and contribute to a high-performing consulting environment

What we're looking for


* Advanced degree (PhD, PharmD, MS) in life sciences or a related field


* 12 years of experience in Regulatory Affairs, with strong focus on strategy


* Experience in a CRO, consulting firm, or client-facing advisory role


* Deep expertise in:



* CMC and/or nonclinical regulatory strategy


* Advanced therapies (e.g., cell & gene therapy, biologics)

Proven success leading...