Director, Regulatory Pre-Award Strategy - UK

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.

What the Director, Regulatory Pre-Award Strategy does at Worldwide:

• Accountable for senior-level leadership in establishing the operational strategy and achieving high performance and growth objectives for global regulatory affairs.
• Oversees the delivery and performance of regulatory affairs activities and supporting roles such as Regulatory Affairs Managers and Regulatory Affairs Specialists.
• Provides expert regulatory advice and contributes to regulatory project work for internal and external customers.
• Responsible for regulatory affairs-related business development activities by attending key Proposal Strategy Meetings, contributing to proposals and bid defense meetings.
• Stays informed as a subject matter expert of changing regulatory affairs requirements and ensures the regulatory affairs group is proactively trained.
• Remains current and knowledgeable with SOPs, ICH GCP and regulatory and quality regulations.
• Fosters professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers.
• Responsible for the preparation of technical/master study documentation in accordance with study requirements.
• Accountable for the performance and development of Regulatory Affairs Managers and Regulatory Specialists.
• Ensures high quality performance of deliverables within the projects assigned to line reports.
• Provides expert regulatory knowledge with the Site Activation functional leads to establish risk mitigation strategies.
• Manages regulatory affairs team workload and provides input for allocations.
• Builds, develops, coaches and leads a team of direct reports responsible for regulatory affairs activities globally.
• May attend customer facing meetings related to Governance, bid defense, and escalation.
• Participates in the development and maintenance of departmental processes, tools, policies, SOPs and associated documents.

What you will bring to the role:

• Strong oral and written communication skills.
• Strong and proven leadership and organizational management skills.
• Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint.
• Expert understanding of clinical research principles and processes.
• Demonstrated ability to independently manage multiple tasks in a fast-paced environment.
• Excellent interpersonal skills in a fast-paced, deadline oriented, and changing environment.

Your experience:

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR a two-year college curriculum or equivalent education/training and eight years’ experience within clinical research.
• Minimum 10 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience.
• Proficient in cross-cultural communication and proficient in both spoken and written English.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed.