Regulatory Affairs Manager

Regulatory Affairs Manager

Type: Permanent

Location: Pancras Square

Introduction to role

Deliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through provision of local regulatory expertise. Support the development of AstraZeneca investigational and in-licensed/co-development products through valued contributions to cross-functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.

Accountabilities

Generate Competitive Licences (0-40%)

Regulatory Compliance & Governance (0-10%)

Commercial Support (0-15%)

Formulate and Influence Regulatory Strategy (0-15%)

Lead the Organisation and Improve productivity (0-10%)

Clinical Support (0-10%)

Essential Skills/Experience

• Life Sciences Degree or appropriate professional qualifications

• 4+ years experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company.

• Post-Brexit UK Regulatory experience

• Business Relationship Management and ability to navigate and coordinate cross-functional interactions

• Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role

• Regulatory Strategy Development

• Demonstrable negotiation skills

• Ability to make optimal use of IT systems

• Use of external regulatory environment and scientific knowledge skills to build a productive, positive and trustworthy relationship with local health authorities to drive meaningful interactions to the benefit of patients

• Lifecycle maintenance of the licenses, including different types of submissions including but not limited to CMC, Labelling, etc.

• Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines

• Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies

• Application of the knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities

• Application of Drug Development Knowledge - Target level: Developing

• Audit and Inspection Knowledge - Target level: Developing

Desirable Skills/Experience

• Therapy Area Expertise in one of Oncology, injectable biologics, medical devices

• Experience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indications

• Change Enablement - Target level: Developing

• Management of reaction to change & remaining effective in new work situations & times of uncertainty; Assessment of, planning for & managing the impact on partners arising from changes & applying change management techniques to appropriately engage partners

• Application of Disease & Therapeutic Area Knowledge - Target level: Performing

• A robust understanding of the disease and therapeutic area including the regulatory and health technology assessment environment in the major markets, competitor landscape, and predictable barriers/obstacles in development

At AstraZeneca, we change the practice of medicine by generating compelling medical evidence that helps physicians better treat patients at every point in their journey. Our cross-functional teams work seamlessly together, demonstrating diverse skills to advance our pipeline and redefine cancer treatment. We foster a culture of openness, transparency, ambition, and drive. Here, you will find a supportive environment where you can grow your career while making a significant impact on patients' lives.

Ready to make a difference? Apply now!

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.