Title Regulatory Affairs Manager - EU CTR Location United Kingdom Experience 5+ years in Medicinal Products Regulatory Affairs with experience in EUCTR / CTIS Responsibilities

Provide critical support in developing global regulatory strategy, planning and execution of global investigational submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL) Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges. Perform independent QC on prepared CTA submissions which include submission documents and structured data populated within the CTIS and IRAS submission portals. Act as a liaison while coordinating CTA activities with other multidisciplinary teams. Provide support for preparation, submission, lifecycle, and archival of CTA submissions and correspondences. Assist with development of assigned regulatory operations work instructions. Stay abreast with updates for regulatory and/or industry standards Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019. Demonstrated performance in managing and producing time-intensive deliverables. Strong attention to detail in data entry accuracy and in following specific process steps within procedural documents. Knowledge of Document Management Systems (Documentum-based is preferred) Recent experience in submitting regulatory submissions using Health Authority Portals. Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint. Recent experience with regulatory applications such as CTAs is preferred.

Skills

Proven performance in managing and producing quality time-intensive deliverables. Highly developed project management skills Proven ability to solve complex issues through innovative problem solving Well defined written and oral communication skills Knows how/when to apply organizational policy or procedures to a variety of situations Demonstrates flexibility in dealing with change and diversity. Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment. Successfully engaged in multiple initiatives simultaneously.

Seniority level Mid-Senior level Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing #J-18808-Ljbffr