Director, Regulatory Affairs

Role Overview

• Provide regulatory strategy advice and support the development and execution of regulatory strategies and plans
• Ensure regulatory milestones are met to support approval strategies and overall business goals of the company
• Plan, prepare and/or review submissions to regulatory authorities including FDA, EMA and other regulatory authorities to support the conduct of clinical trials and approval of marketing applications (e.g., IND, CTA, NDA/BLA, MAA)
• Plan, author and/or review nonclinical and clinical study documents, including but not limited to: Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), nonclinical and clinical summaries and scientific publications
• Plan, author and/or review chemistry, manufacturing and controls (CMC) documents, including but not limited to: CMC sections of regulatory applications as well as supporting records summarizing manufacturing process development and validation, analytical method development and validation, comparability study protocols and reports, stability study protocols and reports and justification of shelf-life/expiry dating
• Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards
• Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders and support development of proactive mitigation plans for identified risks
• Collaborate with vendors who support regulatory operations-related tasks
• Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures
• Identify and communicate regulatory system enhancement needs or technical issues
• Assist with regulatory inspection activities, as necessary.

Requirements

• Bachelor’s Degree required
• Master’s Degree in a life sciences discipline preferred
• Minimum 7 years of progressive experience in drug development and regulatory affairs and/or operations required
• Must have experience with regulatory submission documents including documents required for IND, CTA, NDA/BLA, MAA, and other related submissions
• Direct experience in interactions with health authorities and performing country and region-specific submissions
• Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
• Possess a willingness and ability to work hands-on and with a high level of detail-orientation, in a fast-paced, entrepreneurial environment
• Strategic agility, strong critical and logical thinking with ability to analyze problems
• Ability to establish and maintain collaborative working relationships with internal and external stakeholders.