Because the quality of Otonomy’s employees is the key to our success, we carefully select each new employee. As a team, we value honesty, integrity, knowledge, leadership and a commitment to quality and improvement in everything we do. We want our decisions and actions to demonstrate these values. We are committed to developing products that will benefit people’s lives and build value for our shareholders. We treat one another with respect and take pride in the significant contributions that come from teamwork and the diversity of our organization. We strive for excellence and sound, responsible decision making. We know that the success of Otonomy depends on each of us as individuals and as a member of our team.
We will always strive to select the most qualified candidate regardless of race, color, religion, sex, national origin, ancestry, age, medical condition, sexual orientation, marital status, pregnancy, physical or mental disability, veteran or other protected status. We are proud to be an Equal Opportunity Employer with commitment to Affirmative Action for Minorities, Women, Individuals with Disabilities and Veterans.
Regulatory Affairs Manager
Provide coordination and administrative support in the development, submission and tracking of a variety of regulatory filings. Research regulatory guidance and precedence for Otonomy project support. Prepare training materials and train internal customers on various regulatory compliance issues. Provide support to Clinical Operations for various site activities including protocol/protocol amendment review and submission, investigator document review and submission. Assist in the development and implementation of regulatory strategies, policies and procedures.
Bachelors’ degree in a scientific discipline or the equivalent education and experience. 5+ years of relevant experience in the pharmaceutical or biotech industry. Must have familiarity with submissions to the FDA. EU experience a plus. Knowledge in project management practices and tools and the overall drug development process necessary. Must have background working in the interdisciplinary team environment. Strong verbal and written communication skills and detail orientation required. Must be proactive, independent, hard-working and committed to achieving difficult goals.
Please send your resume with salary requirements to firstname.lastname@example.org
or mail to 6275 Nancy Ridge Drive, Suite 100, San Diego, CA 92121, attention Human Resources.
Otonomy is an Equal Opportunity Employer