OUR COMPANY
We, at RegASK www.regask.com are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care).
RegASK team is highly diverse with more than 10 nationalities across 3 continents, entrepreneurial and very agile, enjoying the benefits of working across industries and across the globe. RegASK just completed its series A funding round in December 2022 and is currently recruiting highly motivated talents to expand its team and support its ambitious growth plans.
RegASK is an international, diverse and rewarding place to work. If you are a builder, highly autonomous in your working style, and eager to problem solve, we would love to hear from you.
RegASK is part of Sprim Global Investments portfolio (https://www.sprim.net), a group of 500+ people in 19 offices across 6 continents, finding solutions, discovering and implementing new ideas to deliver better health.
THE POSITION
Title: Head of Regulatory Affairs (Pharma)
RegASK is a digital platform, using artificial intelligence for augmenting regulatory research. Our technology routinely monitors, anticipates and reports updates or changes to relevant regulations, providing instant alerts. Our platform also allows us to zero-in on applicable regulations to identify and analyse any gaps in the compliance of a product.
RegASK is currently looking for a Head of Regulatory Affairs (Pharma) to join Its growing global Regulatory Affairs team. This leader will have oversight on all content generated on the platform and all RA projects and will be responsible for managing client expectations, watching timelines and budgets, and keeping abreast of client needs.
The Head of Regulatory Affairs (Pharma) should have a strong Pharma and life Science Industry background and will be active in delivering regulatory assessments for Pharma and Medical Devices in link with internal and external experts. The company operates for clients worldwide. This Individual needs a solid understanding of Clinical Trials, submissions process and overall Life Science Industry Regulatory environment.
In this role, you will benefit from the mentorship of highly skilled experts and you will be working in a fast-paced environment managing multiple projects at once, which involve stakeholders across the company.
Reporting to: CEO
Key Responsibilities:
Client Satisfaction:
- 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 the customer satisfaction
- Advise clients on regulatory matters as needed
- Meet clients and present the outcomes of the regulatory assessments during teleconference or in face-to-face meetings
- Lead the projects and liaising with experts as to understand the client scope for proper assistance
Content Strategy:
- 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
Content Delivery:
- 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.
Leadership :
- Coach, Grow and Develop the team to maximize their Engagement, Performance and Potential
- Live the company Culture & Values and drive a positive team culture where team members feel valued, empowered and developed
- Communicate with your team, peers and leaders in a genuine, transparent way, to maximize the flow of information and support effective collaboration
Profile Required:
- 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 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
Preferred experience:
- 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 (APAC, Europe, US and/or LATAM projects)
