Regulatory Affairs Director

Summary

Join Generate:Biomedicines as a Regulatory Affairs Director and provide strategic leadership and operational oversight for regulatory activities related to the development and approval of biologic therapies. You will play a pivotal role in shaping and executing global regulatory strategies, leading interactions with regulatory agencies, and ensuring compliance. The ideal candidate will have a strong background in regulatory affairs, with specific expertise in initial IND filings and regulatory interactions. The role may involve additional responsibilities in regulatory CMC product development. The position offers the flexibility of remote work with required travel to the Somerville, MA office. Generate:Biomedicines is committed to equal employment opportunity and enforces a mandatory COVID-19 vaccination policy.

Requirements

• 10+ years in the biotechnology/pharmaceutical industry with a minimum of 8+ years spent in Regulatory Affairs
• Bachelor’s degree (required), with an advanced degree in a scientific discipline preferred
• Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
• Strong interpersonal skills and problem solving/decision making skills
• Demonstrates the ability to work independently as well as a team member
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
• Experience supporting regulatory submissions for biologic drugs
• Experience with eCTD requirements and electronic submissions
• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities

Responsibilities

• Develop and execute comprehensive global regulatory strategies to support the development, approval, and commercialization of biologic therapeutics
• Serve as the primary regulatory representative in cross-functional teams, providing strategic guidance and risk assessment
• Lead the planning and execution of regulatory applications, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and Biologics License Applications (BLAs)
• Provide regulatory expertise for product development, including CMC, nonclinical, and clinical aspects
• Oversee the preparation, review, and submission of high-quality regulatory dossiers, including briefing books, meeting requests, and responses to health authority questions
• Ensure compliance with US, EU, and ICH regulatory requirements throughout the product development lifecycle
• Collaborate with Regulatory Operations vendor to ensure efficient electronic submissions (eCTD)
• Maintain archival of submissions and health authority communications in Veeva RIM system
• Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company
• The role may also take on additional CMC product development responsibilities depending on experience

Preferred Qualifications

• Expertise in oncology and/or immunology and inflammation therapeutic areas is preferred
• Experience with early development programs is preferred
• Experience with Veeva RIM is a plus
• Background in regulatory CMC, with experience in preparing Module 3 and IMPD-Quality sections for regulatory submissions and familiarity with current Good Manufacturing Practices (cGMP) and quality guidelines is a plus

Benefits

Location: Open to remote; travel required to Somerville, MA office as business dictates