Job Requirements: 

• Master’s or PhD degree in pharmacy or equivalent field  

• Minimum of 5+ years of experience in regulatory affairs within the biopharmaceutical or biotechnology industry, with specific expertise in cell and gene therapy products. 

• Proven track record of successful regulatory submissions and approvals for biologics products in the US market, including INDs and BLAs. 

• In-depth knowledge of FDA and EMA regulations, guidelines, and procedures related to cell and gene therapy products. 

• Strong understanding of the drug development process, including clinical trial design, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) requirements. 

• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies. 

• Strategic mindset with the ability to think critically, anticipate regulatory challenges, and develop innovative solutions. 

• Domain expertise in Cell Therapies manufacturing is a plus. 

• Excellent verbal, written, presentation and interpersonal skills. 

• Strong analytical and problem-solving skills. 

• Proactive, creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks. 

• Stakeholder management internally and externally. 

• Excellent written and verbal communication skills. 

• Ability to work independently and as part of a team. 

• Ability to manage multiple projects simultaneously. 

• Strong attention to detail. 

• Ability to work under pressure. 

Job Responsibilities: 

• Develop and implement global regulatory strategies for cell and gene therapy products to support successful product development, registration, and commercialization in the global market. 

• Prepare, review, and submit regulatory documents, including Investigational New Drug (IND) applications, Biologics License Applications (BLAs), and other regulatory submissions to the regulatory agencies, ensuring accuracy, completeness, and adherence to regulatory requirements. 

• Stay abreast of relevant regulations, guidelines, and industry trends pertaining to cell and gene therapy products. Interpret regulatory requirements and provide guidance to internal teams to ensure compliance throughout the product lifecycle. 

• Collaborate closely with internal stakeholders, including Research and Development, Clinical Operations, Quality Assurance, and Manufacturing, to integrate regulatory considerations into product development plans and timelines. 

• Serve as the primary point of contact for regulatory agencies, including the FDA, representing the company in interactions such as pre-submission meetings, regulatory submissions, and responses to inquiries. 

• Identify potential regulatory risks and develop mitigation strategies to address them effectively. Proactively assess regulatory implications of changes to product development plans and provide recommendations to minimize regulatory impact. 

• Monitor regulatory developments, competitive landscape, and industry best practices related to cell and gene therapy products. Provide insights and recommendations to inform strategic decision-making and maintain a competitive edge.