Manager, Clinical Trial Strategy And Submissions

Summary

Join AbbVie as the Manager of Clinical Trial Strategy and Submission, delivering clinical development regulatory strategies and operations for a portfolio of compounds globally. You will ensure alignment with global and regional regulatory strategies, manage submissions, and interface with regulators and internal teams. Responsibilities include maintaining regulatory databases, participating in process improvements, and supporting inspections. This remote-eligible US-based role requires a life sciences degree, extensive pharmaceutical and regulatory affairs experience, and a strong understanding of global clinical trial legislation. AbbVie offers a comprehensive benefits package.

Requirements

• A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required
• Minimum of 6 years’ experience in the pharmaceutical industry with at least 5 years’ experience in Regulatory Affairs including extensive global clinical trial experience
• Experience of managing multi-national programs of CTAs
• Excellent understanding of the legislation governing the conduct of global clinical trials (in particular but not only EU Clinical Trial Regulation, IVDR, MDR etc.) and evolving regulatory environment, Good Manufacturing Practices and Good Clinical Practices, ICH and other pertinent guidelines relating to the manufacture and release of clinical trial supplies

Responsibilities

• Deliver CTA regulatory strategies & operations for a designated portfolio of development compounds in specified geographic region: WE, EEMEA, LA and specified JAPAC countries in alignment with the overarching global regulatory strategy and region-specific requirements
• Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team (GRPT) and study teams within the development operations organization
• Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial Regulation, IVDR, MDR regulations) and company procedures
• Primary interface between AbbVie and regulators for EU-CTR assessment procedures
• Primary interface between global subject matter expert functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes
• Populate and maintain regulatory databases (COSMOS & HAQit and any other document management systems as applicable), data collation and tracking of regulatory submissions
• Participate in development of internal working procedures. Represent regulatory perspective in cross functional process improvement initiatives
• Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results
• Liaise with Global, Area and Affiliate Regulatory Affairs, Quality Assurance, Regulatory Operations, Clinical Product Development and Supply Chain to identify, resolve and elevate potential issues arising from regulatory approvals and maintenance of CTAs and/or compliance with AbbVie and industry standards. Modify and develop company procedures as necessary. Lead and participate in continuous improvement initiatives within CTS and cross functionally
• Support internal and external inspections and cross functional process improvement initiatives. Follows company policies and procedures for regulatory record keeping. Regularly informs regulatory management of important timely issues and the impact on the global program
• Supports the Associate Director with planning and tracking of regulatory activities and agency interactions

Preferred Qualifications

Knowledge and experience of medical device legislation as relates to clinical trials is preferable

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs