Regulatory Affairs Principal Strategist - Clinical Operations

December 13

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ClinChoice

Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology

Description

• Location: UK – Homebased • Schedule: Permanent • Responsible for developing and implementing regulatory submission strategies for the European Union region • Lead regulatory activities, developing regulatory strategies, addressing regulatory questions and concerns • Participate in proposal preparation and bid defenses • Collaborate with global teams to support regulatory submission management and study startup activities

Requirements

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology) or equivalent; advanced degree preferred. • Minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on the clinical development phase. • Extensive knowledge of global regulatory submission and approval processes. • Proven ability to manage regulatory submissions. • Strong communication and leadership skills. • Experience with global regulatory submissions and health authority interactions. • Experience with the EU CTIS portal. • Understanding of both medical device and pharma regulations • Ability to manage multiple projects in a fast-paced environment. • Strong problem-solving and decision-making abilities. • Previous experience as a national and/or regional regulatory liaison for a product in the clinical development phase. • Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. • Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format.

Benefits

• Excellent work-life balance • Dedicated Line Manager • Monthly meetings with line manager • Full performance and development process with end of year reviews • Team events and end of year party • Career opportunities within in ClinChoice, locally and globally • Employee satisfaction survey - your feedback is important for continuous improvement

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