Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
About AstraZeneca
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Respiratory & Immunology Regulatory Science and Strategy
AstraZeneca's pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I) two of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior Director level). With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.
The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the respiratory therapy area, with the intention of achieving successful registration and lifecycle management to serve patient needs.
This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
What you'll do
Providing regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents. May represent Astra Zeneca as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
Actively be up to date on latest regulatory requirements and trends.
Can provide support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment and resource needs.
Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
Education, Qualifications, Skills and Experience
Essential for the role:
A Bachelors Degree in a scientific or pharmaceutical discipline.
10+ years of Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
Experience providing strategic regulatory advice for the global development of products in several major jurisdictions such as EU, US, China, Japan through all stages of development including pre-approval and marketed assets.
Successful track record in registering and overseeing regulatory strategies for assets.
Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
Strong interpersonal, and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
Desirable for the role:
Previous experience with FDA advisory committee and EMA oral explanation would be a plus
Previous experience working on due diligence activities and in a business alliance environment.
Ability to work strategically within a complex, business critical and high-profile development program.
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!
Competitive salary and benefits package on offer.
The annual base pay (or hourly rate of compensation) for this position ranges from $207,658 to $311,487. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales 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 coverage in accordance with the terms and conditions of the applicable plans. Additional details 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 to modify base pay (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.
Where can I find out more?
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
