AstraZeneca · 1 week ago
Senior Regulatory Affairs Director (Vaccines & Immune Therapies)
Gaithersburg, MD
Full-time
Onsite
Director/Executive
$212K/yr - $317K/yrAstraZeneca is a global biopharmaceutical company, and they are seeking a Senior Regulatory Affairs Director to develop and implement regulatory strategies for vaccines and immune therapies. The role involves leading regulatory projects, ensuring compliance, and collaborating with various teams to achieve rapid product approvals and advantageous labeling.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
Accountable for product maintenance, supply and compliance activities associated with marketed brands
Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures
Leads the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities
Works collaboratively with the global/regional/local regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements
Leads the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
Leads the review of key submission documents and identify any potential risks along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling
Creates, communicates and updates the Regulatory Strategy Document for assigned products/projects. Ensures appropriate consultation and Peer Review. Defines the regulatory development plan and own the planning and construction of the global dossier and core prescribing information
Provides regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
Ensures excellent understanding of the commercial/business goals to contribute as an equal partner with medical and commercial colleagues in cross functional delivery of business objectives
Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Approximate number of people managed in total (all levels) - varies
Matrix Manager – (projects/dotted line)
Manager of a team
What is the global remit? (how many countries will the role operate in?): 2 or 3 countries at a minimum of 40% of time
Qualification
Required
Bachelor's Degree in Life Science or related discipline, advanced degree a plus
Substantial direct experience of working at the Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority
Proven leadership and program management experience
Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment
Preferred
Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions
Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
Leadership – effectively role models the culture & values and expertly guides the team to its common mission
Coach and mentor to others – sought out to mentor others and identifies as well as develops regulatory talent, with commitment to learning and personal development
The ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
Courage in communicating regulatory decisions and/or risks which will be met with resistance by key stakeholders
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
Founded in 1999
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Pharmaceutical Technology
2026-01-19
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