Regulatory Affairs Consultant, In Silico Modeling

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Regulatory Affairs Consultant, In Silico Modeling

We are looking for a Regulatory Affairs Consultant to support several ongoing projects at about 10-20 hours per week. This role is remote.

• Work closely with Pharmatech and our client’s executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the client’s product.
• Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management.
• Plan and oversee activities in support of all regulatory submissions.
• Serve as the primary company contact with the US FDA to achieve company regulatory objectives, fostering strong relationships and acting as a credible, reputable, and effective advocate for the company.
• Provide regulatory guidance to the client across all areas of regulatory affairs throughout all 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 insight and expertise.
• Lead 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.

• Advanced degree from an accredited college or university in science or biomedical engineering, plus a minimum of 10 years of experience filing global regulatory applications for 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 the submission of licenses and authorizations for the maintenance of existing products; including international registrations, dossiers, and execution of regulatory strategies that align with business deliverables.
• Provide regulatory affairs support during internal and external audits.
• Plan schedules for regulatory deliverables on a project and monitor the project through completion.
• Communicate business-related issues or opportunities to the next management level.

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.