Regulatory Submission Manager

This is a fully remote position, open to applicants in Poland, +3 more countries.

📋 Description

• Drive the global strategy and management of submissions for assigned protocols.

• Collaborate with study teams to oversee necessary regulatory activities, standards, and deliverables linked to the development of CTA submissions.

• Lead and participate in relevant meetings to advocate for realistic timelines, comprehend project strategies, evaluate impacts, and present the status of global submission deliveries.

• Support and spearhead global team efforts to ensure that submission components are of high quality and compliant.

• Serve as a liaison with the Sponsor Core team, SSU, and Study Management concerning essential core and local documentation throughout HA and EC submission and translation processes.

• Prepare, review, and provide support for Sponsor submissions to HA/Regional CTA Hub to secure clinical trial authorizations and approvals.

• Coordinate translations for core submission documents.

• Manage the compilation and core package build, contributing to CTA and documentation authorship.

• Handle incoming requests for information by monitoring the RFI mailbox and CTIS portal, reporting RFIs to study teams, and coordinating responses.

• Process payments related to regulatory submissions.

• Act as a local country liaison as needed.

• Escalate, inform, and resolve issues that affect submission builds or the logistics of global submission delivery.

• Discuss dossier requirement interpretations with relevant Sponsor SMEs.

⛳️ Requirements

• Extensive experience with CTIS for document uploads and/or Veeva is essential.

• A B.S./B.Sc in Pharmacy, Life Sciences, Business, or Information Technology is preferred.

• Relevant professional experience of equivalent value will be considered.

• In-depth knowledge and proven execution of CTA and Central Ethics processes.

• Demonstrated technical aptitude and the ability to swiftly learn and utilize new software, regulations, and quality standards.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.