What are the responsibilities and job description for the Regulatory Systems Consultant position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Details:
- Must Have Skills (Top 3 technical skills only)
- Regulatory Submissions
- eCTD, Volume 3
- Pharma Chemistry Manufacturing and Controls (CMC)
- Nice to have skills (Top 2 only)
- Good documentation skill
- Good communication skills
Education/ Certifications (Required):
- BS/MS, Life sciences, pharma, biotechnology or relevant experience
Top 3 responsibilities you would expect the subcon to shoulder and execute:
- DocSet Issues, Market View Issues, Supporting Document Issues, Market Impact Assessment Issues, Document Outline Issues, Product Change Form (PCF) Issues, Metadata Issues, Reporting Issues.
- Data changes include updates to metadata, updating/correcting creation of change control forms, market assessments, impact assessments in collaboration with strategists/SMEs in the business. May also need creation/set up of product dossiers.
- Periodic updates to stakeholders
Desired years of experience:
- 5 years
Additional Information
All your information will be kept confidential according to EEO guidelines.
