Description
Job Description:A Bay Area based company is seeking a Regulatory Affairs Manager in the Pharma industry for their growing team. The Regulatory Affairs Manager will be responsible for the preparation of regulatory submissions, strategies, and support of the product's business needs.
Responsibilities:
- Responsible for leading a team that delivers timely compilation of all documentation for regulatory submissions to support technical work of regulatory submissions.
- Responsible for proper written content and format of regulatory submissions comply with all regulatory bodies and relating to the development and licensure 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 regulatory rules and regulations.
- 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 in a timely manner.
To find out more about Real please visit www.realstaffing.com