Regulatory Affairs Manager

ASTRAZENECA UK LIMITED; City Of London; On-site; GBP 55,000 - 75,000; Full time

Job summary

A leading pharmaceutical company seeks a Regulatory Affairs professional to ensure compliance and drive regulatory strategy for clinical trials in the UK. This role requires over 4 years of experience in Regulatory Affairs, excellent negotiation skills, and the ability to manage relationships with local health authorities. The position offers the opportunity to impact patient care positively.

Qualifications

• 4+ years of experience within a Regulatory Affairs organisation.
• Post-Brexit UK Regulatory experience.
• Operational regulatory experience in the pharmaceutical industry.

Responsibilities

• Ensure timely delivery of clinical trial approvals.
• Drive regulatory strategy for new initiatives.
• Maintain compliance with regulatory standards.

Skills

Negotiation Skills

Relationship Management

IT Systems Proficiency

Business Relationship Management

Lifecycle Maintenance of Licenses

Education

Life Sciences Degree or professional qualifications

Tools

Veeva systems

Job description

Overview

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 the provision of local regulatory expertise. Support the development of AstraZeneca's 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

Responsibilities

• 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%)

Qualifications

• Life Sciences Degree or appropriate professional qualifications
• 4+ years of experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company
• Post-Brexit UK Regulatory experience
• Business Relationship Management and the ability to navigate and coordinate cross-functional interactions
• Operational regulatory experience in the pharmaceutical industry, with time spent in a commercially aware role
• Demonstrable negotiation skills
• Ability to make optimal use of IT systems
• Use of the 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 a 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
• Audit and Inspection Knowledge

Desirable Skills/Experience

• Therapy Area Expertise in Regulatory Affairs Therapy Area lead Respiratory and Immunology (R&I) & Vaccines and Immune Therapies (VI)
• Experience in creating and delivering regulatory strategies for new Marketing Authorization Applications and Clinical Line Extensions
• Experience working in Veeva systems
• Management of reaction to change & remaining effective in new work situations & times of uncertainty; Assessment of, planning for & managing the impact on stakeholders arising from changes & applying change management techniques to appropriately engage stakeholders
• 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, leveraging 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.