Senior Director Regulatory Affairs

Position Summary

The Senior Director will lead global regulatory strategy and operations across development pipeline. This includes :

Developing and executing regulatory strategies

Overseeing submissions : INDs, CTAs, NDAs, BLAs, MAAs

Partnering with internal teams and external agencies

Leading regulatory interactions with FDA and ex-US authorities

Key Responsibilities

Serve as regulatory lead on cross-functional teams

Prepare and manage regulatory documents and submissions

Evaluate regulatory risks and develop mitigation strategies

Maintain regulatory systems, SOPs, and documentation

Monitor global regulatory changes and provide strategic insights

Conduct due diligence for business development

Mentor junior team members

Qualifications

Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline

10+ years in regulatory affairs, 5+ years at Director level or above

Strong knowledge of FDA and international regulatory bodies (EMA, MHRA, Health Canada)

Experience with accelerated pathways , eCTD , and RIMS tools

Background in immunology, dermatology, or rare diseases is a plus

Compensation & Benefits

Salary : $250,000 - $275,000 / year

Equity : Eligible

Benefits : Health, dental, vision, pet insurance, 401(k), paid parental leave, life & disability insurance, referral bonuses

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