Regulatory Affairs Expert
4 days ago
Job Overview:
The Regulatory Affairs Expert will play a pivotal role in ensuring the compliance of pharmaceutical products with regulatory requirements. This position involves providing scientific input for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with internal stakeholders to ensure successful project delivery.
Key Responsibilities:
- Prepare Red Books for key therapeutic targets
- Provide scientific understanding and training to relevant stakeholders
- Evaluate claims as per regulations and technical requirements
- Conduct research studies to support claims
- Handle consumer and medical queries received through consumer care
- Review FAQs to consumer care team
- Liaise with internal stakeholders to ensure OTIF delivery of projects
Requirements:
This role requires a strong background in regulatory affairs, preferably in the pharmaceutical sector. The ideal candidate should have experience in preparing Red Books, training teams, and working on OTC drugs. Additionally, they should be well-versed with regulations such as the D&C Act, DMR Act, and UCPMP.
Salary: $120,000 - $150,000 per annum, depending on experience.
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