Regulatory Affairs Expert for Pharmaceutical Compliance
hace 2 semanas
At ICON Strategic Solutions, we're seeking a highly skilled Regulatory Affairs Expert to join our team. In this critical role, you'll play a pivotal part in ensuring the compliance of pharmaceutical products with regulations and guidelines.
About the JobThis is an exceptional opportunity for a seasoned professional to leverage their expertise in regulatory affairs to drive success in the pharmaceutical industry.
Main Responsibilities- Regulatory Knowledge: Excellent understanding of Cofepris regulations, including drug promotion/advertising and labeling requirements.
- Document Management: Experience with Veeva Vault PromoMats or similar document management systems is a plus.
- Labeling and Advertising: Demonstrated expertise in regulatory requirements for labeling and advertising materials.
- Compliance: Experience in reading, interpreting, and evaluating regulatory guidance documents to ensure regulatory compliance.
- Experience: Minimum 5 years in the pharmaceutical/biotechnology industry, with at least 3 years in regulatory affairs and advertising/promotion review and approval.
- Qualifications: Bachelor's degree in a health, life sciences, or medical field.
- Languages: Fluency in English and Spanish (read, write, and speak).
We're committed to providing an inclusive and accessible environment for all candidates. Our diverse workforce drives innovation, allowing us to better serve our people, patients, customers, and communities.
ICON Strategic Solutions offers a range of benefits to support your well-being and work-life balance, including annual leave entitlements, health insurance, competitive retirement planning, and more.
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