Regulatory Affairs Associate

Bring out the best in each other, and yourself, by working together as one

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace!

Who we are

Our workforce reflects the people we serve – diversity is embedded in everything we do. We’re at our best and most creative when drawing on our different views, experiences and strengths.

How we do it

A place of ownership, each of us is empowered to lead at every level. Backed with great tools, resources and investment. We get things done.

Why we love it

You will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work.

What you’ll do

As a Regulatory Affairs Associate in Cambridge, you’ll work within AZ’s Biopharmaceuticals R&D Late Cardiovascular, Renal and Metabolism team (CVRM), a patient-centric organization collaborating to deliver valuable medicines that address unmet patient needs in cardiovascular, renal and metabolism-driven disease.

The Late CVRM team accomplish this within an agile, hardworking and highly motivated team that sustainably follows the science, data and technology to accomplish our goal of ultimately achieving disease control and clinical remission in these disease areas.

Within the Late CVRM Regulatory Affairs Team you will support the development and execution of regulatory strategies for global programs across the entire lifecycle by proactively using and applying the broad regulatory and scientific expertise, leadership skill and discernment to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.

Position Description:

The Regulatory Affairs Associate (RAA) assists the Regulatory Affairs Management (RAM) team in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards for designated therapy areas and products.

Major Responsibilities:

  • Input regulatory knowledge, intelligence & information into relevant systems and databases maintaining data accuracy and up to date information for the group and relevant databases and platforms.
  • Maintain documentation & records management in EDMS (ie, Veeva Vault or ANGEL) in accordance with defined standards & process and as requested by RAMs & Global Regulatory Execution teams (GRETs) eg. support with Submisison Ready standards/Housestyle skills & QA checks, specific authoring tasks, liaison with Regulatory Operations
  • Support the product registration and maintenance of designated product applications in accordance with AstraZeneca standards of regulatory compliance
  • Provide support across the group for assigned non-drug project roles & responsibilities, eg. as a designated point of contact for external partner, provide specific technical expertise.
  • Be the interface with HA/HA systems for designated regulatory tasks, eg. co-ordination & logistics for HA meetings, management of HA fees, receipt of incoming HA correspondence
  • Responsible for ordering & tracking of specific regulatory requirements eg. i) registration samples, ii) Certificates of Pharmaceutical Product & associated legalization where appropriate iii) any other legal documentation eg. Letters of Authorization, Powers of Attorney, Translations as required.

Minimum Requirements:

  • Relevant experience from elsewhere in Pharmaceutical Industry
  • Some regulatory/medical/technical experience
  • Good commercial and product awareness
  • Some knowledge of regulatory submission, compilation, publishing and approval processes, standards, systems and tools.

Skills and Capabilities

  • Good Communication and influencing skills
  • Good IT/IS skills
  • Project planning and organisational skills – Focus on delivery and results
  • Flexibility and adaptability
  • Interpersonal and networking skills
  • Independent and Team working
  • Proactivity
  • Problem solving

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 13th July 2021 and we welcome with your application; CV and cover letter, no later than 27th July 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

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