Regulatory Contractor

Summary: The Regulatory Contractor role at a global pharmaceutical company in Maidenhead involves providing regulatory expertise for Clinical Trials. The contractor will manage Clinical Trial Applications (CTAs), ensuring compliance with regulatory requirements and supporting submission strategies. This position requires collaboration with various stakeholders to deliver effective clinical development regulatory strategies. The role demands a proactive approach to communication and project management within a complex matrix environment.

Key Responsibilities:

• Manage a portfolio of Clinical Trial Applications (CTAs) including preparation and distribution of documentation.
• Provide advice on submission strategy and country requirements, and operational support for regulatory submission preparation.
• Review and input on documents related to clinical trial submissions managed by other stakeholders.
• Ensure compliance with approved company CTA processes and timelines.
• Monitor key project milestones and communicate issues/changes to stakeholders and management.
• Support inspection readiness activities and maintain awareness of regulatory intelligence.
• Populate relevant databases and activity trackers within agreed timelines.
• Provide technical support on document preparation and undertake necessary training for compliance.
• Comply with company policies and procedures to meet statutory and quality requirements.

Key Skills:

• Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
• 3-5 years of CTA experience, preferably in global clinical trial submissions.
• Strong IT skills, including proficiency in MS Word, Excel, PowerPoint, and Adobe Acrobat.
• Proactive verbal and written communication skills.
• Strong interpersonal, organizational, and team working skills.
• Ability to manage multiple activities and understand business needs related to regulatory issues.
• Critical reasoning skills for problem identification and resolution.
• Strong project management skills.

Salary (Rate): undetermined

City: Maidenhead

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other