Senior Regulatory Affairs Director (Vaccines & Immune Therapies)

AstraZeneca - Vaccines & Immune Therapies

At AstraZeneca, weare committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we playedan important roleas part of a truly global effort to respond to a new and unprecedented challenge.We will continue to advance science in vaccines and immune therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people.

Role

TheSeniorRegulatory Affairs Director(SRAD)leads the global regulatory strategy for complex products. They aim to secure rapid approval that meets business, market, and patient needs. TheSRADoffers strategic leadership and hasexpertisein global regulatory science, drug development processes, and strategies for high-profile programs. Familiarity with the disease area is essential to influence cross-functional discussions with Global Product Teams (GPT) and stakeholders. They can serve as the Global Regulatory Lead (GRL) for a product groupand alsoact as a regional lead based on their location.

Your strategic leadership skills and deep understanding of global regulatory sciencefrom early to late-stage development into commercialisation strategywill be crucial in influencing cross-functional discussions and guiding high-profile development programs, as well as interacting with Global HealthAuthorities.Are you prepared to take on the Global Regulatory Lead role and drive innovative strategies for regulatory success?

Responsibilities

• Effectivelylead ordeputise for Therapeutic Area (TA)VP/Regional VP in senior-level interactions internally or externally, includingcontributions tointernal governance 

• Develop and implement regulatory strategies for products, ensuring rapid approval withadvantageouslabeling.

• Lead the planning and construction of global dossiers and core prescribing information.

• Conduct regulatory risk planning and mitigation.

• Serve as the single point of contact and Global Regulatory Affairs representative on Product Development Teams.

• Lead the Global Regulatory Sub-teamto ensure regional regulatory needs are incorporated into the Global Regulatory Strategyand ensure execution on strategy.

• Deliver all regulatory milestones, assess regulatory success probabilities, and implement risk mitigation measures.

• Partner with marketing and regional regulatory affairs staff tohelpshape theenvironmentandHealthAuthorities' views on relevant topics.

• Lead regulatory staff on complex projects to ensure prioritizedobjectivesare delivered on time and with quality.

• Ensure effective regulatory representation at health authority meetings with clear documentation of discussions.

• Lead the development and updates of the Regulatory Strategy Document for complex projects.

• Monitor changes in the regulatory environment andadviseGlobal Product Teams accordingly.

• Provide regulatory leadership in product in-license/due diligence review, divestment, and withdrawal.

• Lead complex projects designed to improve efficiencies and simplification, spanning cross functional areas.

Skills/Experience

• Advanced degree in a science-related field and/or otherappropriate knowledge/experience.

• At least 10years experienceor equivalent of regulatory drug development includingsuccessful contribution to a major regulatoryapprovalat a global level.

• Experience in Infectious Diseases is strongly preferred.

• Must havepreviousexperience in leading Major Health Authority interactions (e.g., FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).

• Proven leadership and program management experience, as well as the ability to think strategically and critically evaluate risks to regulatory activities.

• Ability to work strategically within a complex, business-critical and high-profile development program.

Why AstraZeneca?

At AstraZenecawe’rededicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.There’sno better place to make a difference to medicine,patientsand society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning,growthand development.We’reon an exciting journey to pioneer the future of healthcare.

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue tocreate a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $211,581.60 - 317,372.40.However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right tomodifybase salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.