About the Organization:
PAREXEL is a leading global biopharmaceutical service provider that supports the biotech and pharmaceutical industries by aiding in the development of innovative drugs and treatments. They specialize in knowledge-based contract research, medical communications, and consulting services across therapeutic areas for pharmaceutical, biotechnology, and medical device sectors worldwide.
Position Details
Role: Manager, Regulatory Affairs
Location: Bengaluru, India
Industry Type: Pharma/Healthcare/Clinical Research
Experience Required: 10+ years of relevant experience in Clinical Trial Regulatory Submissions
Job ID: R0000024245
End Date to Apply: 30th December 2024
Key Responsibilities:
- Regulatory Submission Expertise:
- Handle Clinical Trial Regulatory Submissions.
- Act as Regulatory Lead for global trials, particularly focusing on the European market.
- Manage the CTIS database and submit EU CTRs.
- Project Leadership:
- Provide guidance to project team members and prioritize team workloads.
- Facilitate issue resolution and decision-making within project guidelines.
- Implement strategies for improved project efficiency and performance.
- Performance Management:
- Manage performance reviews, salary actions, and bonus processes for team members.
- Ensure compliance with PAREXEL policies and alignment with local staff regulations.
- Client & Quality Focus:
- Produce high-quality work meeting client expectations.
- Review team deliverables for quality assurance.
- Development & Networking:
- Participate in self-development activities and maintain industry knowledge.
- Engage with relevant scientific or technical associations.
Qualifications:
- 10+ years of experience in managing clinical trial studies and regulatory submissions.
- Expertise in European market regulations and CTIS database usage.
- Strong leadership and conflict resolution skills.
- Ability to produce quality deliverables under tight deadlines.
How to Apply:
Interested candidates can apply by visiting the PAREXEL careers page and searching for Job ID R0000024245.
Application Deadline: 30th December 2024