Head of Regulatory Affairs, Cell Therapy Immunology

AstraZeneca • Boston, MA

2d • $266,597 - $399,895 • Onsite

About The Position

Join us at AstraZeneca, where we are using cell therapy to redefine the treatment of life-threatening immune-mediated diseases. Our exceptional team is working on the ground breaking area of cellular therapies, and we are investing in internal capabilities to discover and accelerate the delivery of next-generation cellular therapies 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. The Head of Regulatory Affairs, Immunology Cell Therapy should be comfortable interacting with senior leaders, a tough negotiator, can make decisions in ambiguity, decisive leader, and a realist while providing global strategic regulatory expertise and oversight to support products through research, development and commercialisation. Their expertise applies to early, late and post-marketing development stages for cell therapy products being developed for immune-mediated diseases. The role will quickly navigate new environments or tackle opportunities while developing a growing organization. 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. How you will make a difference: Provide oversight, partner with, and mentor RADs and SrRADs to produce strategies for a product/group of products in the Immunology Cell Therapy TA 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 area. 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 cell and gene 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

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
• Broad experience of the therapeutic area, with specific cell therapy immunology regulatory sciences expertise and immune-mediated diseases.
• 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

• 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 Immunology Cell Therapy TA 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 area.
• 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 cell and gene 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

• 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: Mid Level
• Number of Employees: 5,001-10,000 employees