RegASK is hiring a
Head of Regulatory Affairs in Worldwide

Summary

The job is for a Head of Regulatory Affairs (Pharma) at RegASK, a global RegTech company serving the LifeSciences and FMCG industries. The role involves managing regulatory affairs projects, ensuring client satisfaction, developing content strategy, and leading the team. The candidate should have a strong background in Pharma and Life Science Industry with at least 15 years of experience.

Requirements

• Relevant degree in Pharma, Life Sciences, Biotech industry or equivalent
• Min. 15 years experience related to responsibilities including clinical trials regulatory compliance, authoring of regulatory dossier documentation (including eCTD Modules 1 – 5​), regulatory strategy, product classification, pre-submissions/submissions, etc
• Ability to embrace and engage in digital and AI strategy
• Previous experience leading global teams and driving projects to meet deadlines and budgets
• Details oriented and able to handle regulatory information and submissions with high degree of accuracy
• Excellent communication skills and client-facing skills
• Ability to create effective and lean PowerPoints
• Skilled in human interactions within multicultural teams, including ability to challenge other experts when deemed justified
• Enjoy working for innovative companies in challenging and demanding environment
• Organized, analytical and result-oriented individual who enjoys a fast-paced entrepreneurial environment
• Ability to plan multiple priorities concurrently

Responsibilities

• Manage the team of Regulatory Affairs (Pharma, Medical Devices, Clinical Trials…) and ensure that projects are delivered on time and with the expected quality
• Ensure customer satisfaction
• Advise clients on regulatory matters as needed
• Lead the projects and liaising with experts as to understand the client scope for proper assistance
• Support on identifying the client scope/need and propose a methodology to tackle the request
• Liaise with Marketing, Product and Sales teams and feed them with Customers feedback and requests
• Supervise the content on the platform
• Identify internal areas of improvement and propose best practices to the team
• Liaise with clients and SMEs and coordinate with the team for content delivery
• Write parts of projects and participate in strategy and deliverable development
• Review technical reports, presentations, and other client’s deliverables
• Manage RA day to day activities
• Understand the technical issues of the project(s) and find solutions to solve problems

Preferred Qualifications

• Based in US or Europe
• An advanced degree in science and/or Regulatory Affairs
• Experience with decentralized clinical trials (DCT)
• Experience with Medical Devices submissions
• Consulting experience in Regulatory Affairs Industry and/or with Regulatory Authorities
• Broad experience across a variety of therapeutic areas
• Global experience (Europe, APAC, US and/or LATAM projects)