Regulatory Affairs Consultant
India, Remote Job ID R0000020373 Category Regulatory / Consulting Date Posted 04/24/2024Overview
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
Job Description:
- Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.
- Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
- Knowledge of EU country regulations
- Able to contribute as local SME for countries and collaborate with global team and other stake holders for increasingly more complex regulatory submissions for Clinical Trial Applications.
- Experience in handling health authority queries
- Good understanding and knowledge of ICH guidelines and Ethics Committee requirements for Clinical Trial Applications in EU countries.
- Clear oral and written communication skills
- Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work in different time zones and ability to work independently.
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