Director, Regulatory Affairs

Summary

Join Natera as the Director, Regulatory Affairs, leading regulatory activities for products throughout their lifecycle. You will develop and implement global regulatory strategies, collaborating with stakeholders and guiding product teams. Responsibilities include preparing regulatory applications, managing projects, and mentoring direct reports. Success requires effective communication and navigating a fast-paced environment. This role involves overseeing multiple programs across various therapeutic areas. Natera offers competitive benefits and a collaborative work environment.

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
• Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions
• Hands-on experience in managing the preparation and timely submission of regulatory applications, such as US IND or CTA, is required
• In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
• Ability to work independently
• Exceptional written and oral communication
• Strong computer skills, including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet

Responsibilities

• 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
• Provides interpretation of regulatory guidance documents, regulations, and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

Preferred Qualifications

• Knowledge of current CMC regulations outside of the US, as well, is preferred
• Regulatory expedited program submissions, CMC, and EU CTA experience is a plus
• Experience with managing third-party vendors, regulatory operations, and consultants is a plus

Benefits

• 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
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program