Director of Regulatory Affairs

3 days ago

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AL Solutions

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A global headhunting team supporting the Life Science industry across the UK, EU, USA.

trials • consulting • health economics • market access • clinicalresearch

11 - 50

Description

• Develop and implement comprehensive global regulatory strategies for immunology products, encompassing clinical, nonclinical, and CMC aspects. • Collaborate with internal and external stakeholders to develop sound development strategies and operational plans. • Lead the preparation and submission of high-quality regulatory documentation (IND, CTA, BLA, MAA) to support early- and late-stage clinical programs. • Represent Regulatory Affairs in cross-functional development teams and ensure alignment with regulatory requirements. • Lead communications with global health authorities (FDA, EMA, etc.), including preparing for and conducting formal regulatory meetings. • Stay informed about global regulatory changes and competitive developments to assess their impact on company programs. • Guide cross-functional teams in identifying and mitigating risks associated with regulatory challenges.

Requirements

• Bachelor’s degree in Life Sciences (Master’s or PhD preferred). • At least 10 years of experience in Regulatory Affairs within the biopharma industry, with a strong focus on immunology or autoimmune therapeutic areas. • Extensive experience in global regulatory strategy, including filing IND/CTAs, and familiarity with BLA/NDA/MAA submissions. • Proven ability to navigate regulatory requirements at all stages of drug development in a global environment. • Strong track record of managing relationships with health authorities, including FDA and EMA. • Demonstrated success in leading regulatory meetings and providing strategic advice to cross-functional project teams. • Excellent communication and leadership skills, with experience managing direct reports preferred.

Benefits

• Comprehensive medical, dental, and vision insurance for employees and their dependents. • Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA), and a 401(k) plan with employer match. • STD, LTD, Basic Life, AD&D, and voluntary insurance options. • 3 weeks of PTO, 5 sick days, and 12 holidays annually. • Cell phone and internet subsidies, commuter benefits, employee referral bonuses, annual bonus programs, and stock options. • An annual training budget for continued education and career advancement.