Website:
apsida.co.uk
Job details:
Job Title: Regulatory CMC Data Management Consultant
Location: India (Remote)
Duration: 6 months
Workload: Up to 150 hours/month
Start: ASAP
Company Overview
Apsida Life Science is partnering with a leading global clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development and delivery of innovative therapies. With decades of industry experience and a global presence, the organisation provides expertise in clinical development, regulatory consulting, market access, and real-world evidence to help bring new treatments to patients worldwide.
Key Responsibilities:
- Support data migration activities for the internal CMC regulatory database.
- Perform data remediation to identify and resolve data inconsistencies, inaccuracies, and gaps.
- Review and validate CMC regulatory data and documentation to ensure accuracy, completeness, and consistency.
- Support regulatory database management and data quality improvement activities.
- Collaborate with Regulatory Data Strategy and Regulatory Intelligence stakeholders to resolve data-related issues.
- Identify opportunities to improve database usability and enhance the end-user experience.
- Contribute to continuous improvement initiatives relating to regulatory data management processes.
Requirements:
- 5+ years Regulatory Affairs and CMC experience in the pharmaceutical industry.
- Experience in Regulatory Intelligence within the pharmaceutical industry.
- Experience supporting regulatory databases and data management activities.
- Demonstrated experience with data migration and data remediation projects.
- Familiarity with CMC regulatory data and documentation.
- Strong understanding of data quality and validation principles.
- Strong analytical and problem-solving skills, with excellent attention to detail.
- Ability to work independently and manage deliverables effectively.
- Strong communication and stakeholder management skills.
- A continuous improvement mindset, with a focus on data quality and usability.
If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:
kgmphahlele@apsida.com
+44 744 134 1041
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
Click on Apply to know more.
