Regulatory Affairs Consultant

Team Horizon is seeking a Regulatory Affairs Consultant for who are an award-winning Healthcare & Pharmaceutical company based in the Midlands.

Why you should apply:

• Join a dynamic, exciting company with huge growth prospects and a passion for innovation, their people and their products


• Flexible & Hybrid working opportunities

What you will be doing:

• Projects will be assigned to the role in line with business objectives;


• Preparation and delivery of high-quality regulatory submissions and submission management plans for global regulatory agencies.


• Independently prepare regulatory asubmissions and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and work to support the product portfolio.


• Managing regulatory issues, maintaining submission information in relevant systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.


• Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.


• Authoring and/or coordinating submission activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating and contributing to responses to agency queries and performing quality review of regulatory submissions.


• Maintenance of existing global regulatory approvals.


• Prioritizing and independently completing assigned workload appropriately.


• Managing and contributing to regulatory affairs-related projects, initiatives and actions.

What you need to apply:

• Bachelor's degree or equivalent/graduate degree preferred in a science (Biology, Chemistry, Pharmacy or related science) and/or technical discipline.


• Minimum of 5 years of hands-on Regulatory/CMC authoring experience preferable (initial registrations or post-approval variations).


• Experience managing projects is preferable. 


• Action and results-orientated to achievement of goals and objectives.


• Experience with leading and participating in several projects concurrently.


• Ability to accurately scope projects and consider the full impact of decisions and actions taken.


• Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.


• Strong presentation skills, able to engage people in technologies, products & services.


• Functional expert in regulatory affairs with a passion for excellence.


• Attention to detail and accuracy – essential


• Maintains direction & focus through proactive planning & organized approaches to work.


• Resilient to objections, pressure and change in a fast-moving industry.