Passage Bio Overview: Passage Bio is an exciting, fast-paced gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.

 

Job Overview:    

    

The Associate Director/ Director of Regulatory Affairs CMC will play a critical role in establishing regulatory CMC strategies to support overall drug development by providing regulatory advice to technical and clinical teams.  The Director of Reg CMC will ensure timely  execution at fit for purpose quality in accordance with global regulatory guidance and will lead the preparation of the CMC requirements of filings, lead and prepare teams in seeking CMC related Agency advice, and will ensure maintenance of compliance with reporting requirements related to CMC topics.

 

Responsibilities:

• Develop and execute technical / CMC  regulatory strategy to support product development and achieve regulatory milestones
• Lead and direct interdisciplinary teams for CMC regulatory activities, such as submissions and agency meetings
• Act as a liaison with worldwide health authorities and maintain highly effective relationships with them through exceptional written and verbal communication skills, fostering a positive relationship on behalf of the company
• Plan and prepare Quality modules/ documentation in support of  Clinical Trial Applications (CTAs)/Investigational New Drug (INDs) Applications, and marketing authorization applications
• Lead interdisciplinary team to prepare responses to regulatory agency questions, specifically working with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities  
• Maintain current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect CMC drug development
• Ensure compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
• Manage regulatory CMC strategy and submission aspects for rare disease development programs to regulatory authorities
• Lead or participate in meetings with internal stakeholders, external business partners and teams for clinical development programs or collaborations, specifically to communicate regulatory CMC guidance and strategies.
• Ensure regulatory CMC submissions are of high quality, are consistent and complete, and comply with current global regulatory standards by providing critical review of the CMC data packages from other functional team representatives
• Prepare summaries of Agency meetings and contacts for inclusion in the regulatory archives
• Manage post-approval global product activities such as, but not limited to, change control, product complaints, supplements and variations.
• Provide regulatory CMC leadership for due diligence activities and product/company integrations.
• Liaise with other regulatory and operations staff to ensure appropriate project support is provided

Requirements:

• Bachelor’s degree (advanced degree preferred) in a life science field (Biology, Chemistry, or Pharmaceutical sciences)
• 8-10 years’ experience in pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
• 10+ years CMC Regulatory Affairs experience in drug development and product registration activities.
• Demonstrated expert knowledge of regulatory submissions and experience with agency interactions
• Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups
• Prior rare disease experience preferred; cell and gene therapy experience desired.

Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled