Job description
Posted:
90 days ago
Location:
Remote work, United States
Job Ref:
BH-33218-1
Job Type:
Contract
Salary:
$35 - $50 per hour
Expiry date:
1/30/2023
Contact:
Jason Batzofin
Contact Email:
jason.batzofin@sourcegroupinternational.com
Xplore Life Science is hiring an experienced CMC Product Lead.
The role is for a global leading biopharmaceutical company in the USA. The role is completely remote in the EST timezone.
**You must have valid right to work in USA
This is a freelance contract role with a minimum 11-month duration and immediate start.
Responsibilites:
Requirements:
The role is for a global leading biopharmaceutical company in the USA. The role is completely remote in the EST timezone.
**You must have valid right to work in USA
This is a freelance contract role with a minimum 11-month duration and immediate start.
Responsibilites:
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal.
- Manage execution/authoring of CMC documentation (Module 1, 2 and 3) for life cycle management
- Collaborate with client and external partners to support compliant execution of change management
Requirements:
- Knowledge of regulatory guidelines and relevant applications.
- Bachelor's degree required in science, engineering or related field (advanced degree preferred)
- Marketing authorization experience.
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