Labelling Strategy Manager/Labelling Strategy Associate Director

AstraZeneca UK

Location: Bangor, Maine, Cheshire East, Gaithersburg, Maryland

Job Type: Full time

Posted


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?

If so, why noy join our 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!

Getting medicines to market and to the end users who will benefit from them really is what we are all about here at AstraZeneca. Our skilled Regulatory teams are key to that- ensuring that the medicines we produce meet the different requirements to licence them in countries across the world. The Labelling/Labeling strategy teams work on ensuring that the information on the safe and effective use of these medicines reaches the end users - Health care Professionals and patients.

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.

The role:

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.

About you:

Essential Requirements:

  • 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

Preferred Qualifications

  • Advanced academic training is highly desirable (PharmD, PhD)
  • If you have knowledge of major market labelling regulations, this will be an advantage

Why AstraZeneca?

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 position -(UK/IND - Ruth.bannister@astrazeneca,com ; SWE - maria.elmberg1@astrazeneca.com ; or Kellee Briscoe (US) - Kellee.briscoe@astrazeneca.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 closing 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.

Date Posted

21-Nov-2022

Closing Date

11-Dec-2022

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.

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