Regulatory Affairs Manager

AstraZeneca UK

Location: Greater London

Job Type: Full time

Posted


Regulatory Affairs Manager

Location: Pancras Square

Competitive Salary & Benefits

Advert Closing Date: 22nd October 2022

Do you have expertise in, and passion for Regulation? Would you like to apply your expertise to impact the service in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

We use our influence across the enterprise to shape our external interactions. Working across different markets and functions, we listen to all voices, which allows us to optimally represent them when we communicate our products externally.

Our move to Pancras Square offers us the strongest possible platform to transform the lives of patients in the UK, as the country’s leading biopharmaceutical company. It will bring AstraZeneca UK closer to our customers, partners and stakeholders in the UK’s healthcare environment, as well as foster greater collaboration with the wider AstraZeneca footprint.

As a Regulatory Affairs Manager (RAM), you will be responsible for the delivery and maintenance of competitive licences for UK including driving regulatory strategy for new initiatives. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership. The successful RAM will ensure the timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK achieved through provision of local regulatory expertise, supporting the development of AZ investigational and in-licensed/ co-development products through valued contributions to MC3 projects, study feasibility questionnaires, scientific advice meetings and other related activities. You will also be fully compliant with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards.

What will you be doing?

  • Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling

  • Develop professional working relationships with assessors and administrative staff within the regulatory agencies

  • Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications)

  • Defend existing labelling and provide regulatory input into patent defence strategies

  • Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements

  • Assure appropriate standards and policies for all technical aspects of the company’s activities in Regulatory Affairs are adhered to

  • Provide regulatory input/solutions to supply and stock issues

  • Liaise with Operations to manage pack changes and ensure labelling compliance

  • Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence

  • Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence

  • Provide strategic regulatory advice relating to environmental ‘shift’ (e.g. POM-P, duplicates, own label supplies, generics, management of black triangle/ symbol)

  • Project manage and deliver projects of commercial strategic value

  • Ensure focused regulatory input into new product development via MC3 etc. in the UK/EU business interest

  • Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues

  • Ensure appropriate cross functional input into the delivery of optimal licence strategies

  • Proactively identify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and execute workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead

  • Keep up-to-date with developments in the Regulatory

  • Environment and share this knowledge across the department and beyond, in the business interest

  • Ensure optimal departmental processes through continuous review

  • Actively contribute to the development, coaching and training of the department, including new starters

  • Proactively manage the regulatory process for clinical trials for UK

Essential:

  • Life Sciences Degree or appropriate professional qualifications

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

  • Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

  • If still interested, we welcome your application no later than 13th October 2022.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted

10-Nov-2022

Closing Date

07-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.

You’ve got this!