Parexel Hiring Regulatory Affairs Manager in Bengaluru, India
Parexel, a global leader in clinical research and regulatory solutions, is seeking a seasoned Regulatory Affairs Manager to join their team in Bengaluru, India. If you have over 10 years of experience in clinical trial regulatory submissions and a passion for improving global health
Available Position:
Regulatory Affairs Manager
Qualifications:- Over 10 years of relevant experience in Clinical Trial Regulatory Submissions
- Experience managing clinical trial studies and serving as Regulatory Lead for global trials
- Exposure to the European market and expertise in handling the CTIS database and submitting EU CTR is desirable
- India-Bengaluru (Office and Remote options available)
Job Details:
Role Overview: At Parexel, we are committed to improving the world's health by delivering high-quality clinical development solutions. As a Regulatory Affairs Manager, you will play a crucial role in managing clinical trial regulatory submissions, providing guidance to project team members, and ensuring compliance with global regulations.Key Responsibilities:
- 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)
Parexel Hiring Regulatory Affairs Manager[/caption]
