Director of Regulatory Affairs

About the Company:
They are a clinical-stage biotechnology company dedicated to developing a new class of medicines for cancer and autoimmune diseases. Their innovative platform leverages unique antibody technology to provide more effective treatments. Committed to revolutionizing therapeutic options, their growing pipeline of clinical and preclinical assets demonstrates a passion for improving patient outcomes.

About the Role:
They are looking for a Director of Regulatory Affairs to lead the global regulatory strategy for several key immunology programs. As the global regulatory lead (GRL), you will work cross-functionally with teams to manage regulatory submissions and approvals, ensuring compliance with international health authority standards. Your role will be crucial in driving programs through all stages of development.

Key Responsibilities:

• 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

Qualifications:

• 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

Why Join Them?
They offer a fast-paced, collaborative work environment that fosters innovation and personal growth. Their benefits package includes:

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

They are an equal opportunity employer and welcome candidates from diverse backgrounds, including those of all races, genders, sexual orientations, nationalities, and veteran statuses.