Regulatory Consultant, ANDA

Pharmatech Associates, a USP company; San Francisco (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Pharmatech Associates, Inc. in San Francisco, CA seeks a senior Regulatory Affairs professional to lead development of regulatory strategies for successful product registrations and post-approval commercialization.

You will manage ANDA preparation, review, and submission processes, and serve as the primary contact with the US FDA, guiding submissions and regulatory strategy across all stages of product development.

Qualifications

• Advanced degree in science, biomedical engineering, plus a minimum of 10 years of experience in filing global regulatory applications (NDA/ANDA/IND/BLA).
• 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 maintenance of existing products; international registrations and dossiers; execution of regulatory strategies.

Responsibilities

• Lead development of regulatory strategies for successful registration and post-approval commercialization.
• Lead and manage ANDA preparation, review, and submission processes in compliance with FDA regulations.
• Drive execution of regulatory strategy from deformulation to QQ report and ANDA support.
• Plan and oversee activities in support of all regulatory submissions.
• Serve as primary company contact with US FDA to achieve regulatory objectives.
• Provide regulatory guidance across all areas throughout product development.
• Engage with FDA Product Specific Guidances and QbR framework as applicable.
• Participate in internal regulatory team to define and execute strategy.
• Support preparation of briefing packages and regulatory submission documents.

Skills

Regulatory strategy development

FDA regulatory knowledge

ANDA submissions

Lead cross-functional teams

Regulatory project management

Education

Advanced degree in science/biomedical engineering

Job description

Location: San Francisco, CA

Remote Available

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 an 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 company
• Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
• String understanding of the QbR framework and leveraging the FDA’s Product Specific Guidances
• 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 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
• 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

Equal Employment Opportunity

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.