Pharmatech Associates
Regulatory Consultant, ANDA
Pharmatech Associates, San Francisco, California, United States, 94199
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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.
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.
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.
Strong understanding of the QbR framework and leveraging the FDA’s Product Specific Guidance.
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.
Education and Qualifications
Advanced degree from an accredited college or university in science, biomedical engineering, plus a 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 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.
Responsible for communicating business‑related issues or opportunities to next‑level management.
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.
Apply
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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.
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.
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.
Strong understanding of the QbR framework and leveraging the FDA’s Product Specific Guidance.
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.
Education and Qualifications
Advanced degree from an accredited college or university in science, biomedical engineering, plus a 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 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.
Responsible for communicating business‑related issues or opportunities to next‑level management.
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.
Apply
#J-18808-Ljbffr