Regulatory Affairs Consultant, In Silico Modeling

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world. Regulatory Affairs Consultant, In Silico Modeling Apply Location San Francisco, CA Full Remote We are looking for a Regulatory Affairs Consultant to support several ongoing projects at about 10-20 hours per week. This role is remote. Job Duties

• Work closely with Pharmatech and our client’s 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 client’s product.
• reputed company, reputed company, and drive the execution of the regulatory strategy from pre-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.
• Provide regulatory guidance to the Client 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 strategy.
• Support the preparation of briefing packages, and regulatory submission documents as needed, providing reputed company and expertise.
• reputed company the integration of in-silico modeling and predictive modeling strategies into regulatory submissions and supporting documents for FDA review and approval.
• Draft, present, and defend regulatory positions to the FDA and other global agencies, leveraging data from in-silico and predictive modeling methodologies as pivotal evidence.
• Guide clients in the design and execution of in-silico and predictive modeling studies to address specific FDA concerns, including support for Q&A sessions, pre-IND, and other regulatory meetings.
• Provide regulatory expertise regarding the acceptance and use of in-silico modeling outcomes in support of submissions, risk assessments, comparability protocols, and predictive stability analyses. Education and Qualifications
• Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 10 years of experience in Filing Global Regulatory Applications for the following registrations NDA’s, ANDA’s, IND’s and BLA’s for pharmaceutical and Biotech products.
• Demonstrated experience preparing briefing packages and leading regulatory defenses before the FDA where in-silico modeling and predictive analytics were significant contributors to the regulatory case.
• Proven record in submission of licenses and authorizations for the maintenance of existing products; International registrations and dossiers and execution of regulatory strategies that align with business deliverables.
• Provide Regulatory Affairs support during internal and external 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. provides equal employment opportunity to 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. Apply Contact Us Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first reputed company? Connecting. Simply fill out our form and a representative will follow-up shortly. 22320 Foothill Blvd. Suite 330, Hayward CA 94541 #J-18808-Ljbffr Apply tot his job Apply To this Job

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