Executive Regulatory Science Director, Respiratory & Immunology

AstraZeneca • Boston, MA

8d • $266,597 - $399,895 • Hybrid

About The Position

Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of our Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life. Executive Regulatory Science Director, Respiratory & Immunology should be comfortable interacting with senior leaders, be a tough negotiator, can make decisions in ambiguity, be a decisive leader, and a realist while providing global strategic regulatory expertise and oversight to support products through research, development and commercialization. Their expertise applies to early, late and post-marketing development stages for respiratory and immunology diseases. They ensure that adequate regulatory resource and skills are provided in line with designated disease area strategies and portfolio to enhance the likelihood of success which meet business needs, health authorities, and patients. They will partner with functions to ensure regulatory experts are assigned to provide strategic regulatory and development advice/direction at the time of key milestone investment decisions across the portfolio.

Requirements

• Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
• More than 10 years drug development experience
• Experience in global regulatory strategy and submissions that have progressed through to registration
• Must have significant experience in leading major Health Authority interactions
• Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
• Experience in managing people in a matrixed organizational structure

Nice To Haves

• Broad experience of the therapeutic area: respiratory / immunology expertise is nice to have.
• Advanced degree in a scientific field (e.g. MSc, PhD, PharmD, MD)

Responsibilities

• Provide oversight, partner with, and mentor RADs and SrRADs to produce strategies for a product/group of products in the therapeutic area that are consistent with the disease area and portfolio strategy. The strategies should be crafted and negotiated with global health authorities (e.g FDA, EMA, CDE) to deliver a rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business and patients.
• Leads discussions in both internal and external forums, providing expertise in regulatory knowledge of disease areas.
• Influences and drives regulatory strategies and recommendations at all stages of development, in early and late development, and for established brands on regulatory components of development specific to respiratory and immunology therapies as well as other tools such as novel endpoints/biomarkers, novel study designs, and digital applications.
• Effectively represent the Regulatory function in senior level interactions at internal governance technical review committees e.g. Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees
• Works in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment
• Defines and drives disease area global regulatory policies and priorities within the TA

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Executive