About the Role
You will be responsible for the delivery of various regulatory affairs projects (both internal and external). You will manage and mentor junior colleagues and review their work. You will manage a portfolio of projects for a number of clients. This will encompass projects in clinical development, at MAA filing stage and post approval lifecycle management.
• Managing regulatory affairs projects (from clinical trials through to post approval variations), for small molecule and biological products and for the UK, EU and US markets. Submissions may include clinical trial applications and amendments, MAA dossiers and variations. As well as, scientific advice requests, PIPs and Orphan drug applications
• Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
• Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business.
• Prepare and manage regulatory submissions and agency interactions.
• Develop regulatory plans to meet project and client goals.
• Interacting with pharmaceutical stakeholders
• Regulatory submissions, regulatory strategy, regulatory authoring
• Project management and leadership
• Researching regulatory affairs topics and content creation
• Review of regulatory affairs learning resources produced by colleagues
• Management and mentoring of junior colleagues and review of their work
Requirements
Over 4 years regulatory affairs experience (pharmaceutical or regulatory agency)
Educated to at least BSc level within Sciences or Pharmacy
Knowledge of ICH, EU and/or US pharmaceutical regulations
Experience of regulatory submissions, regulatory strategy and/or regulatory writing
Project management and leadership
Strong interpersonal skills, teamwork and communication and stakeholder engagement
Organisation and problem solving skills
Willingness to manage and mentor others
About the Company
__About us__
We are a leading product development and regulatory affairs consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market, minimising development costs and ensuring continued supply. We keep our client's needs and the patients who benefit at the heart of what we do.
A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.
Our team offers strategic and operational support in the fields of CMC and regulatory, which guide products efficiently from early development to marketing approval and post-approval maintenance.
Furthermore, we provide exceptional regulatory affairs training courses
__Our Values__
Flexibility - We offer employees a flexible working environment in their quest for a work/life balance and to support their diverse personal situations. Our flexibility is reflected in how we strive to accommodate clients’ needs.
Trustworthy: We pursue honesty, accuracy, fairness, and transparency to uphold trust. We have great integrity
Innovation - We train our staff to enable them to provide innovative and creative approaches in the regulatory support they provide.
Pioneering: We are at the forefront of the latest developments in the regulatory space. We keep our knowledge up to date, evaluate new developments and contribute to the progression of the regulatory profession
Contribute to Society: We support and empower professional knowledge sharing communities.
We aspire to help people lead longer, healthier lives.
Build Greatness out of Diversity: We celebrate our diverse backgrounds and appreciate that our different perspectives allow us to achieve our best. We are inclusive and treat everyone with respect.
Dauntless in Spirit: We aim high, remain competitive, strive to achieve our goals, and never give up.
Professional: We deliver our goals with the greatest level of professionalism and conduct and are authoritative in what we do
Bold: We are forward-looking, flexible, innovative and embrace change
Build Greatness out of Diversity: We celebrate our diverse backgrounds and appreciate that our different perspectives allow us to achieve our best. We are inclusive and treat everyone with respect.
Customer Focus: We keep patients, pharmaceutical clients and professionals at the front of our daily work and collaborate to solve critical regulatory and business challenges. We deliver valuable learning and professional development experiences. We provide full end to end solutions for our customers problems rather than just services.
__Benefits__
• Pay dependent on relevant experience
• Part-time
• Work from home role
• Mentorship by seasoned regulatory professional
• Career progression opportunity
• Opportunity to join a rapidly growing organisation, enabling a vast range of learning opportunities