Description
Job Description:A San Francisco Bay Area company is seeking a Senior Regulatory Product Manager in Technical Regulatory Affairs for their expanding team. The Senior Regulatory Manager will be responsible for the preparation of regulatory submissions and strategies supporting the product's lifecycle and business needs.
Responsibilities:
- Responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions.
- Responsible for ensuring content and format of regulatory submissions comply with all regulations and relating to the development, licensure and marketing of drugs or biologics.
- Developing strategies for the support of marketed biological products.
- Work with cross-functional teams in developing global strategies for products and marketing.
- Provide support for discrepancy, change, control, and inspections as directed.
Requirements:
- Strong understanding of CMC regulatory.
- Bachelors in Biology or Life Sciences preferred.
- Must have a proven ability to communicate effectively in both a written and verbal format.
- Ability to lead communications with FDA and other regulatory bodies to facilitate review and approval of submissions.
To find out more about Real please visit www.realstaffing.com