Regulatory Affairs Consultant Safety/Labelling
Poland, Remote Additional Locations Bucharest,Romania Job ID R0000026952 Category Consulting Date Posted 09/17/2024Overview
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 an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.
Key responsibilities will include:
Acting as expert for labelling-related activities
Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
Developing, supporting and reviewing labelling and/or safety-related content
Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities
Skills and experience:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
3-5 years of experience in an industry-related environment
Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
Experience interacting with a regulatory authorities
Critical thinking and problem-solving skills
Project leadership and management knowledge
Excellent interpersonal and intercultural communication skills, both written and verbal
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