Manager, Regulatory Affairs
Bengaluru, India Additional Locations: Bengaluru, Karnataka, India Job ID R0000024245 Category Regulatory / Consulting Date Posted 07/05/2024Overview
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
- 10+ yrs relevant experience in Clinical Trial Regulatory Submissions.
- Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.
- Expertise in handling the CTIS database and submitting EU CTR is desirable.
- Provides guidance to project team members
- Works within broad project guidelines and facilitates issue and conflict resolutions
- Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
- Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
- Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
- Produces quality work that meets the expectations and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
- Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives
- Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)
- Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country
- Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear
- Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
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