Parexel Hiring Regulatory Affairs Manager

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

Location:

• 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:

1. Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.
2. Expertise in handling the CTIS database and submitting EU CTR is desirable.
3. Provides guidance to project team members
4. Works within broad project guidelines and facilitates issue and conflict resolutions
5. Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
6. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
7. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
8. 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
9. Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives
10. Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)
11. Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country
12. Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear
13. 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)

How to Apply:

Interested candidates can apply online through the Parexel careers page. Join us and be part of a team that takes our work personally, does it with empathy, and is committed to making a difference.

Apply Online: Parexel Careers – Regulatory Affairs Manager