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Regulatory Affairs Specialist

3 months ago

London, United Kingdom AstraZeneca Full time

**Regulatory Affairs Specialist
- Fixed Term Contract (Parental Cover)**

**Location: Pancras Square**

**Competitive Salary & Benefits**

**Advert Closing Date: 11th Feb 2024**

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 craft 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 collaborators 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.

The role is for a 12-month parental cover.

**What will you be doing?**
- 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
- 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 supervising invoices to ensure timely payments to suppliers. Liaise with EBS to ensure timely payment
- Coordination and active liaison with MHRA finance team to maintain and resolve payment issues, maintaining department logs and supervising 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 Data pharm, RNIB etc)
- Proactively identifies and implements opportunities for new administration systems and processes to improve office efficiency

**Crucial**:

- 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 efficient use of IT systems

**Desirable**:

- Experience in the pharmaceutical industry with time spent in a commercially aware business role

**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 c