Description
JOB DESCRIPTION:A San FranciscoBayarea company is seeking a Director of Regulatory Affairs for their growing team. The Director of Regulatory will act as primary liaison for procedures, strategy, submissions, FDA, post market activities, and all corporate goals.
RESPONSIBILITIES:
* Prepares and manages submissions with departments outside the Regulatory Affairs such as INDs, CTAs, NDAs.
* Actively take part in project teams and provides support in identifying and assessing regulatory risks for regulatory strategies.
* Interacts directly with all US regulatory bodies.
* Manages Regulatory departments.
* Supporting the product development team and assessing technical discrepancies that clearly are supported by data.
* Manages, reviews, edits, and advises on corporate publications, labeling, advertising and promotions.
* May be responsible for conducting performance reviews and feedback for department.
Requirements:
* Bachelor's/Master's degree in scientific, health care or related field or equivalent. Minimum of 10 years of pharmaceutical industry experience with 5+ years of regulatory experience required.
* In- depth understanding of pharmaceutical development and FDA requirements.
* A leadership role in project teams with approximately 30% of time in meetings.
* High proficiency in MS Word to create documents, edits, and submits.
To find out more about Real please visit www.realstaffing.com