FSP Regulatory Affairs Consultant - CMC vaccines
Czech Republic, Remote Additional Locations: Bucharest, Bucureşti, Romania; Budapest, Budapest, Hungary; Prague, Czechia; Vilnius, Lithuania Job ID R0000003864 Category Regulatory / Consulting Date Posted 09/23/2022Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are currently looking for a client dedicated Regulatory Affairs Consultant with CMC vaccines experience.
In the role of a Regulatory Affairs Consultant you will have strong technical skills and may be developing specialist knowledge of a particular subject and/or market. You will ensure the timely performance of work within a project scope to the quality expectations of the client. When serving as a Project Lead or Work Stream Lead, you will assure the work of the entire team or work stream is delivered on time and that it meets client’s and quality expectations.
This role can be based in Poland, Hungary, Romania or Lithuania - office or home based.
Job Responsibilities:
Coordination/authoring of Module 2.3 and Module 3 dossiers, including new registration dossiers of 2 new vaccines, minor and major variations on various products with declination to other markets, renewals, PQVAR, US and CA Annual Reports
Coordination of CMC Module 1 submission, including WHO submissions, PQVAR activities, APR for all products
Lead/Coordination of a team of CMC professionals
Skills and Experience required for the role:
University degree in a science discipline
At least 5 years CMC experience, with vaccines preferred
Module 3 Authoring Experience, preferred
Specific CMC LCM expertise in supporting Major/Minor Variations, Renewals and HA RTQs, M1 authoring
Working knowledge of Regulatory Systems (Veeva Vault, Veeva RIM, etc.)
Very good project management skills
Fluent English, French language skills are a plus
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