Regulatory Affairs Specialist
Location: Greater London
Job Type: Full time
Regulatory Affairs Specialist
Location: Pancras Square
Competitive Salary & Benefits
Advert Closing Date: 24/02/23
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 Specialist (RAS) you will be responsible for delivering and maintaining competitive licences for UK commercial brands whilst ensuring regulatory compliance for defined products and project responsibilities, including project leadership. You will be at the forefront of ensuring the timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK achieved through provision of local regulatory expertise. The successful RAS will need to understand and moderate full compliance 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?
Ensure timely submission and approvals of all licensing applications and compliance with UK regulatory requirements
Assure appropriate standards and policies are maintained for all technical aspects of the company’s regulatory activities are adhered to
Provide regulatory input to stock and supply issues whilst liaising with Operations to manage pack changes and ensure labelling compliance
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 input to responses for European applications)
Actively contribute to cross-functional team working within the Medical & Regulatory Department and other areas of the business
Support the delivery of commercial objectives, including representing Regulatory Affairs on appropriate cross-functional teams
Ensure Prescribing Information is in accordance with the licence
Provide regulatory input relating to commercial brands, including competitor intelligence
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
Identification of regulatory strategies to support commercial and business objectives and company efficiencies
Plan and execute the workload for defined product responsibilities in consultation with the Regulatory Affairs Lead
Proactively manage the regulatory process for clinical trials for UK
Raising POs as required and tracking invoices to ensure timely payments to suppliers. Liaise with EBS to ensure prompt payment
Coordination and active liaison with MHRA finance team to maintain and resolve payment issues, maintaining department logs and tracking spreadsheets to support this activity and ensuring positive and proactive MHRA finance support
Co-ordinates training, training matrices, documentation of training and management of electronic documentation system – updating of SOP’s etc
Point of contact for liaison with external vendors (including Datapharm, RNIB etc)
Organising and maintaining accurate departmental/field email distribution lists, monthly organisation charts & therapy product responsibility lists
Proactively identifies and implements opportunities for new administration systems and processes to maximise office efficiency
Life Sciences Degree or appropriate professional qualifications
Experience working within a RAS role or a similar role
Experience in or awareness of the pharmaceutical industry Demonstrable negotiation skills
Ability to make optimal use of IT systems
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.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn
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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.