Regulatory Affairs Consultants (San Francisco)

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is reputed company, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. We are looking for aRegulatory Affairs Consultant to support several ongoing reputed company at about 10-20 hours per week. This role is remote. Job Duties • Work closely with Pharmatech and our clients executive leadership team to reputed company the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the clients product. • reputed company, reputed company, and drive the execution of the regulatory reputed company from reputed company-IND to launch, commercialization and product lifecycle management • Plan and reputed company activities in support of reputed company regulatory submissions • Serve as the primary company contact with the US FDA to reputed company company regulatory objectives, by fostering strong relationships and acting as a reputed company, reputable, and effective reputed company for company • reputed company regulatory guidance to the reputed company across reputed company areas of regulatory affairs throughout reputed company stages from product development • Experience working with government agencies sponsoring drugs and biologics is highly desirable. Combination Drug and Device regulatory submission experience is a plus. • Participate as part of internal regulatory team to define and execute the regulatory reputed company • Support the preparation of briefing packages, and regulatory submission documents as needed , providing insightand expertise Education and Qualifications • Advanced degree from accredited college or university in science, biomedical engineering, plus a m inimum of 10 years of experience in Filing Global Regulatory Applications for the following registrations NDAs, ANDAs, INDs and BLAs for pharmaceutical and Biotech products. • Proven record in submission of licenses and authorizations for the maintenance of existing products; International registrations and dossiers and execution of regulatory strategies that reputed company with business deliverables • reputed company Regulatory Affairs support during reputed company audits • Plans schedules for regulatory deliverables on a project and monitors project through completion • Responsible for communicating business-reputed company issues or opportunities to next management level Pharmatech Associates, Inc. providesequal employment opportunityto reputed company individuals regardless of their race, reputed company, creed, religion, gender, age, sexual orientation, national reputed company, disability, veteran status, or any other characteristic protected by state, federal, or local law. Contact Us Our unique approach can help your company reputed company the complexities of launching a drug, biologic or medical device into multiple markets. The first reputed company? Connecting. Simply fill out our reputed company and a representative will follow-up shortly. 1.877.787.0177 510.732.0177 #J-18808-Ljbffr Apply tot his job Apply tot his job Apply To this Job