Regulatory Consultant, 505(b)(2)

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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, this role is remote.

Job Duties

• 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.
• The Regulatory Consultant will provide strategic and tactical regulatory guidance for the preparation, submission, and management of 505(b)(2) NDAs. This role requires extensive FDA regulatory knowledge and the ability to manage complex regulatory projects.
• 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 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.

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.
• 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.
• 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‑related issues or opportunities to 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.

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