Regulatory Affairs Consultants

Location: San Francisco, CA (remote role, 10–20 hours per week)

About the role

Support several ongoing projects as a Regulatory Affairs Consultant, working closely with Pharmatech and our client’s executive leadership team.

Responsibilities

• Lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the client’s product.
• 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.
• Provide regulatory guidance 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, providing insight and expertise.
• Provide Regulatory Affairs support during internal and external audits.
• Plan schedules for regulatory deliverables on a project and monitor progress through completion.
• Communicate 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.
• Proven record in submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Experience executing regulatory strategies that align with business deliverables.

Preferred Qualifications

• Experience working with government agencies sponsoring drugs and biologics.
• Combination Drug and Device regulatory submission experience.