We are looking for a Regulatory Affairs, Consultant to join our Regulatory Consulting Team. This is an amazing opportunity to work on regulatory consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, and regulatory strategy, among others, and we would love to speak with you if you have any of the skills or expertise in the regulatory affairs and consulting domain.
About You – experience, education, skills, and accomplishments
1. Bachelor’s or master’s degree in pharmaceutical sciences
2. At least 5 years of relevant work experience in regulatory affairs or in supporting regulatory professional services/ Consulting projects.
3. Relevant experience in clinical trial data optimization, clinical data management, MAA submissions
4. Regulatory Intelligence – Pharmacovigilance, Clinical Trial, New and post approval registrations, etc.
5. Customer facing or customer service experience desirable.
6. Demonstrated ability to learn on new domains, understand internal systems & processes and perform at the same time.
It would be great if you also had. ..
7. Exposure to regulatory consulting
8. Master's degree in regulatory affairs
9. A flexible and collaborative approach to work
10. Ability to prioritize effectively and adopt a systematic approach to tasks
What will you be doing in this role?
Project Delivery Support (70%)
11. Become an integral member of the delivery team within the Life Sciences Consulting group.
12. Act as a point of contact for the customer throughout a project’s lifecycle.
13. Act as the project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.
14. Escalate any project risks and delivery issues to the Manager, Regulatory Services for action and resolution.
15. Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.
16. Deliver on routine projects, new development and one-off requests.
Business development (30%)
17. Support to any received Requests for Information (RFIs) and Requests for Proposals (RFPs).
18. Work with professional services colleagues to provide robust effort estimates for scoped projects.
19. Support the creation of customer facing materials to support commercial discussions such as samples.
20. The role will sometimes require you to work individually or as part of a team with knowledge sharing or as team player.
Projects you will be working on
Various regulatory consulting projects such as data monitoring, content authoring, regulatory landscape, precedence analysis, newsletters, custom dashboards, guidance interpretation, gap analysis. The team works for global clients in multiple domains of clinical and drug regulatory space for multiple product types.
About the Team
The team consists of 22+ colleagues mainly based in Barcelona and reporting to the Senior Manager of Regulatory Consulting, as well as other colleagues in the US, India, and Europe. The Regulatory Consulting Team works towards adding value to data from different sources and providing professional regulatory services to our global clients. The team works with internal databases like Cortellis intelligence, etc., and with external local consultants/ partners. The team here demonstrates good networking skills and establishes rapport with the client and internal/external stakeholders.
Hours of Work
This is a permanent full-time position at 40 hours a week (35 hours during July and August). The working schedule is flexible, mostly centered on CET time zone with occasional need to accommodate late or early meetings with US or East Asia time zones. The position is hybrid going to the office in Barcelona 2-3 times per week.
What We Can Offer You
21. A modern culture environment combined with all the financial and stability advantages of working for a large business.
22. Active volunteering community, with annual paid hours of volunteering time.
23. Private Health and Life & Disability insurances.
24. Tax-free benefits (Ticket Restaurant scheme, kindergarten and transport cards).
25. Language classes (Catalan, Spanish and English).
26. Global and dynamic employee base (more than 20 nationalities).
27. 30 working days of vacation.
#LI-Hybrid, #LI-SK1
At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.