Director of Regulatory Affairs - Remote

Overview

The Director, Regulatory Affairs, will be responsible for leading regulatory activities for one or more products through all stages of a product’s lifecycle. The Director may manage a group of individuals responsible for developing global regulatory strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Director will be expected to provide guidance to the product teams supporting products in their portfolio. In addition, the individual will be responsible for preparation, review, and approval of related agency correspondence and regulatory applications. The candidate will need to successfully manage multiple projects in a fast-paced and results-oriented environment to deliver on bringing new products to market. Effective communication skills will be critical to overall success. The individual will also be expected to mentor and develop their direct reports.

In Short

• Develop / implement effective regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for product development projects
• Review documents for submission-readiness to ensure that all submissions conform to health authority guidelines
• Lead Regulatory discussions and interactions with health authorities to facilitate review and approval of submissions
• Develop regulatory processes and procedures to support regulatory submissions
• Works with Quality Assurance to develop / implement a pharmacovigilance program
• Works with Quality Assurance to establish annual product quality review
• Support the creation and maintenance of CMC submission templates
• Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
• Perform assessment of manufacturing change controls

Requirements

• Minimum 10 years’ experience (BS degree), 8 years’ experience (MS degree), or 6 years’ experience (PhD) in pharmaceutical/biotech industry, manufacturing and/or analytical focus, advanced degree preferred. Experience with biologics a plus.
• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Natera employees and their immediate families receive free testing in addition to fertility care benefits.
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
• Generous employee referral program!