Regulatory Specialist
6 days ago
Team Horizon is seeking a Regulatory Affairs Specialist for 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 submissions 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.
Mid-Senior level
Employment typeFull-time
Job functionOther
IndustriesPharmaceutical Manufacturing and Health and Human Services
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