Regulatory Manager, Clinical Trials Regulatory Management (home-based) Lisboa

Regulatory Manager, Clinical Trials Regulatory Management (home-based)
Lisboa
Lisboa, Lisboa, Portugal

Regulatory Manager, Clinical Trials Regulatory Management (home-based)

Apply locations: Lisbon, Portugal; Barcelona, Spain; Sofia, Bulgaria; Ljubljana – Dunajska, Slovenia; Madrid, Spain

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: R1461041

RESPONSIBILITIES

• Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer.
• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
• Ability to write scientific documents e. g. Investigational Medicinal Product Dossier, clinical trial justifications.
• May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs.
• May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs).
• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
• Deliver regulatory training/presentations as required, internally or externally.
• May mentor junior colleagues and engage in department knowledge sharing.
• May perform additional tasks as deemed appropriate by Line Manager.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development.
• Demonstrates comprehensive regulatory/technical expertise.
• Good negotiating skills and the ability to identify and resolve issues, using a flexible adaptable approach.
• Strong ownership and oversight skills.
• Demonstrated skills in chairing meetings and working on initiatives.
• Ability to work on several projects, retaining quality and timelines and can prioritize workload.
• Ability to propose revisions to SOPs or suggest process improvements for consideration.
• Strong mentoring skills, helping junior colleagues and setting a positive example.
• Innovative and
  - driven.
• Strong skills in establishing and maintaining effective working relationships with
  - workers, managers and clients.
• Strong software and computer skills, including MS Office applications.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life
  - related discipline or professional equivalent plus at least 5 years relevant experience or high school diploma plus at least 9+ years’ experience (or combination of education, training and experience).
• EU-CTR knowledge & experience.
• Global CTA submission experience.

PHYSICAL REQUIREMENTS

• Extensive use of telephone and
  -
  - face communication requiring accurate perception of speech.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.
• Travel might be required.

This role is not available for UK visa sponsorship