Senior Regulatory Content Expert
6 days ago
About this Role
We are seeking a highly skilled Senior Regulatory Content Expert to join our team at Lifelancer. In this role, you will be responsible for creating and editing high-quality clinical and safety documents for submission to regulatory authorities.
Key Responsibilities:
- Write and/or edit complex Clinical Study Reports (CSR), CTD submission documents, medical sections of Periodic Benefit-Risk Evaluation Report (PBRER), Risk Management Plans (RMP), Product and Disease ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports with added knowledge and expertise.
- Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
- Work independently on documents acting as an SME on clinical deliverables, buddy or mentor to the medical and senior medical writers, efficiently peer reviews providing Scientific inputs.
About You
We are looking for a candidate with ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry. You should have excellent communication skills, stakeholder management, and ability to work independently and within a team environment.
The ideal candidate will have expert knowledge of global registration of drugs and demonstrated accomplishment in therapeutic area/domain knowledge exposure, publication submission, and project management.
You should possess an Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters, or bachelor's in science, D Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD).
Estimated Salary: $80,000 - $110,000 per year based on location and experience.
Benefits
- A competitive salary package.
- An opportunity to work with a talented team.
- A comprehensive benefits package.
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