Regulatory Affairs Manager
Location: London St Pancras
Competitive salary, bonus & benefits
Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product responsibilities, manage the regulatory process, and negotiate with regulatory agencies to provide rapid approvals with competitive labelling.
Accountabilities:
As a Regulatory Affairs Manager, you will
- 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
- Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
- Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications)
- Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions.
- 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
- Project manage and deliver projects of commercial strategic value
- 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
- 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 Skills/Experience:
- Life Sciences Degree or appropriate professional qualifications
- Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
Desired Skills/ Experience:
- Therapy Area Expertise in Respiratory & Immunology
- Experience in creating and delivering regulatory strategies
- Postgraduate qualification
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by results and use our unique blend of science and commercial knowledge to spot opportunities and drive outcomes. We are redefining the future of biopharmaceuticals, working towards our vision to be the leader in Cardiovascular, Renal, Metabolism, Respiratory and Immunology by 2025. Our patient-first approach informs every decision we make. Here we believe in digging deep to understand what patients truly need. We're empowered to stay at the forefront - with the resources and support of a leading pharma, and the nimbleness and flexibility of a smaller business.
Are you ready to fuel your ambition and break new ground? Join us in turning our productive pipeline into a reality to impact patients' lives! Apply today!
Where can I find out more?
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.