Senior Regulatory Affairs Director
Senior Regulatory Affairs Director
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Job Description
Do you have expertise in and passion for Regulatory AffairsWould you like to apply your expertise andchannel 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 youre our kind of person.
Respiratory & Immunology Regulatory Science and Strategy
AstraZenecas 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 Strategywill be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Respiratory & Immunology 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 crossRegulatory 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 will be responsible for:
- 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/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 skilldevelopment 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 licensein/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
Education Qualifications Skills and Experience
Essential for the role:
- Bachelors 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.
Desirable for the role:
- 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
Why AstraZeneca
At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.
Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging facetoface in our offices 3 days a week.
So whats next!
Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.
Date Posted
23Apr2025Closing Date
30May2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Employment Type
Full-Time
