Regulatory Consultant, ANDA

Location: San Francisco, CA (remote available)

About the role

We are seeking a highly experienced Regulatory Consultant with deep expertise in Abbreviated New Drug Applications (ANDA) to guide and support our regulatory strategy and submissions. This role is remote.

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.
• Lead and manage ANDA preparation, review, and submission processes in compliance with FDA regulations.
• Develop, lead, and drive the execution of the regulatory strategy from deformulation and the preparation of the QQ report, creation of the ANDA including support of FDA inquiries.
• 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 from product development.
• Demonstrate a strong understanding of the QbR framework and leverage the FDA’s Product Specific Guidances.
• 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 of experience with ANDA submissions and FDA regulatory processes.
• Proven track record of successful ANDA approvals.
• 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.
• Experience in execution of regulatory strategies that align with business deliverables.