Regulatory Consultant, 505(b)(2)

This is a remote role based in San Francisco, CA.

About the role

We are seeking a highly experienced Regulatory Consultant with deep expertise in 505(b)(2) NDA submissions to guide our regulatory strategy and ensure successful product approvals.

Responsibilities

• 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.
• Provide strategic and tactical regulatory guidance for the preparation, submission, and management of 505(b)(2) NDAs.
• Lead and manage 505(b)(2) NDA submissions in compliance with FDA regulations.
• Provide regulatory strategy for new product development, reformulations, and lifecycle management.
• 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 by 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 of product development.
• Participate as part of the 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.
• Provide Regulatory Affairs support during internal and external audits.
• Plan schedules for regulatory deliverables on a project and monitor project through completion.
• Responsible for communicating business-related issues or opportunities to the next management level.

Requirements

• Advanced degree from an accredited college or university in science, biomedical engineering, or a related field.
• Minimum of 10 years of experience in filing global regulatory applications for NDA’s, ANDA’s, IND’s, and BLA’s for pharmaceutical and biotech products.
• Minimum of 10 years’ experience with 505(b)(2) NDA submissions.
• Strong knowledge of 21 CFR Parts 210, 211, 314, and FDA guidance documents.
• 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.

Preferred Qualifications

• Experience working with government agencies sponsoring drugs and biologics is highly desirable.
• Combination Drug and Device regulatory submission experience is a plus.