Do you have a background in Regulatory Affairs and Labelling? Are you a skilled negotiator who is great at building relationships? Would you like to put your skills to use in a role that will ultimately benefit many of our patients?
Then, join us at the Respiratory and Immunology (R&I)/Vaccines and Immune Therapies (V&I) Regulatory Labelling team to get involved in shaping global regulatory labelling strategies and support the research, development and commercialization of our products across the portfolio!
We are searching for an individual to join us as Labelling Strategy Director. This role could be based at one of several of our locations - including Durham, NC Gaithersburg, MD, Wilmington, DE, Macclesfield (UK) or Gothenburg (SWE)
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, 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.
AstraZeneca's pipeline of innovative medicines is consistently growing and within the R&I/V&I Regulatory Labelling strategy team we take innovative labelling approaches to bring these life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently as possible. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.
The Labelling Strategy Director provides regulatory labelling expertise and guidance, typically for more complex drug projects and across specific therapy/disease areas and cross-functional teams. This position will contribute to develop and craft the strategic direction of the labelling component of the regulatory strategy for sophisticated projects and/or disease areas along with the maintenance of Core Product Information (CPI) and US/EU Market Product information (MPI) for assigned AstraZeneca marketed or pipeline products. The individual has a key role in the labelling group by sharing knowledge, mentoring peers, and advising the respective Labelling Therapy Area Senior Director Group Manager to ensure appropriate project and resource planning.
What You'll Do:
- Ensure that the labelling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Develop the strategy to align with the overall product regulatory strategy by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
- Lead the Product Labelling Team (PLT) in the preparation and maintenance of high quality Core Product Information, EU Quality Review of Documents, US Prescribing Information, Instructions For Use through to Senior Leader approval with the aim of achieving advantageous labelling.
- Lead labelling negotiation strategies, anticipating health authority perspectives.
- Provide labelling expertise to the cross functional teams for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
- Provide clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
- Evaluate, interpret and communicate global regulations and trends on labelling and any business impact these might have on product labelling.
- Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
- Develop labelling documents, policies, procedures and SOPs.
- Bachelor's degree (or equivalent) in Science or related discipline
- Demonstrative experience, including regulatory experience, in a pharma company, preferably working with labelling
- Knowledge of labelling regulations and guidances
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
- Advanced academic training is highly desirable (PharmD, PhD)
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines
is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Come and join our journey.Next Steps - Apply today!
To be considered for this exciting opportunity, Please do wither apply directly through our website or get in touch with one of our Recruitment team for this role (UK - Ruth.bannister@astrazeneca,com., SEW - Maria.elmberg@ Astrazeneca.com or Kellee Briscoe (US) - Kellee.email@example.com) who can help provide you with more information. If you know someone who would be a phenomenal fit, please share this posting with them.
Recruitment for this role is ongoing, and we have not specified a close date so your early application is appreciated.
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
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.