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Regulatory Affairs Specialist, Americas Rare Diseases
4 weeks ago
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Americas Rare Diseases. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for advertising and promotional materials for our rare disease products in the United States.
Main Responsibilities
- Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
- Facilitate review meetings and coordinate with authors, reviewers/approvers to get content approved to support business needs.
- Ensure regulatory compliance while effectively managing business risks.
- Understand global promotional strategies and provide solutions to local US regulatory promotional issues.
- Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled, and warning letters to pharmaceutical companies published by OPDP.
Requirements
- Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs.
- Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP.
- Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus.
About Us
Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years experience, operating in 30 countries with more than 6,000 employees. We are committed to improving peoples quality of life by acting responsibly towards society and the environment.
