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(Senior) Regulatory Affairs Consultant CMC small molecules
Primary Location: Romania, Bucharest Additional Locations: Croatia, Remote; Croatia, Zagreb; Hungary, Budapest; Hungary, Remote; Poland, Remote; Poland, Warsaw; Serbia, Belgrade; Serbia, Remote Job ID R0000036853 Category Regulatory Affairs Date Posted 11/19/2025Overview
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
Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented (Senior) Regulatory Affairs Consultant with CMC writing background (small molecule) to join our growing team!
As a (Senior) Regulatory Affairs Consultant CMC at Parexel, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.
The role can be office or home based.
Role Responsibilities:
- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders, attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
Skills and experience required for the role:
- University degree in a life science discipline
- Solid regulatory experience in EU, other non-EU markets preferred
- Proficiency in Module 1 and 3 writing
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English, written and spoken
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