Labelling Strategy Manager / Labelling Strategy Associate Director
Location: Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Are you experienced within Regulatory Affairs and Labelling? Do you possess good negotiating skills and are good in building relationships? Then, join us at the Cardiovascular, Renal or Metabolism (CVRM) Regulatory Labelling team to get involved in shaping global regulatory labelling strategies and support the research, development and commercialization of our CVRM products across the portfolio!
AstraZeneca’s pipeline of innovative medicines is consistently growing and within the CVRM Regulatory Labelling strategy team we take innovative labelling approaches to bring these CVRM 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 CVRM 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.
We are now seeking a new member to join our team in the role as Labelling Strategy Manager or Labelling Strategy Associate Director (depending on your experience). This role can be located in either of our dynamic sites in Gaithersburg (US), Macclesfield (UK), Gothenburg (Sweden) or Bangalore (India).
What You’ll Do:
Working in the role as Labelling Strategy Manager or Labelling Strategy Associate Director, you will provide regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT).
This role leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) / European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. You will also have the opportunity to contribute by sharing expertise and mentoring peers.
Your main accountabilities/responsibilities:
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.
Interpret regulations, competitor analyses, and anticipating / communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
Lead the PLT in the preparation and updates of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
Contribute/ lead the development of labelling negotiation strategies, anticipating Health Authorities perspectives.
Provide labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional regulations and guidances.
Provide clarity regarding applicable labelling requirements and expectations in sophisticated situations to relevant partners, including risk insight and proposing mitigations.
Evaluate, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
Ensure appropriate communication across labelling sub-functions.
Support and communicate the labelling rationale to Senior Leaders to enable effective decision making.
Do you have the essential qualifications for these roles?
To be successful in this role, we believe that you have a University degree in Science or related field. A minimum of 1-3 years pharmaceutical experience including regulatory experience preferably working with labelling is required to apply for the role as Labelling Strategy Manager. To be considered for the more senior role as Labelling Strategy Associate Director, more than 3 years is required. Both roles require knowledge of labelling regulations and guidance.
We believe that you possess good negotiation skills as well as building relationships. You have excellent written and verbal communication skills and are keen to attend to detail and accuracy and have the ability to assimilate clinical and scientific information and present it in a concise manner. The role requires someone with the ability to think strategically, appropriately assess risks and formulate strategies to manage risks. If you have knowledge of major market labelling regulations, this will be an advantage.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Welcome with your application (CV and cover letter) no later than 30 November, 2022. We will review the applications continuously so please apply as soon as possible.
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.