Field Regulatory Specialist

EMD MILLIPORE • Madison, WI • 6d ago

JOB REQUIREMENTS: Duties and Responsibilties of Job: Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That\'s why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your role: Regulatory Guidance: Provide expert advice to customers on the regulatory considerations for the use of transfection reagents and/or enhancer products as ancillary materials in cell and gene therapy applications. Customer Engagement: Act as the primary regulatory point of contact for customers, helping them navigate regulatory questions and challenges related to FDA IND filings and commercial manufacturing. * Risk Mitigation: Develop supporting collateral and communicate strategies to mitigate regulatory risks for customers using our products in their manufacturing processes.

Collaboration: Partner with field application scientists and account managers to ensure alignment in customer interactions and provide integrated technical-regulatory support. Regulatory Compliance: Stay updated on global regulatory requirements and guidelines (e.g., FDA, EMA, ICH) for ancillary materials and ensure our recommendations are in line with current standards. Documentation Support: Present Mirus regulatory documentation to customers (e.g. Regulatory Support Package and/or Product Safety Risk Assessment- Supplemental Information). Assist customers in preparing documentation to support regulatory submissions, including technical dossiers, risk assessments, and compliance statements. Training & Education: Conduct training sessions for internal teams and customers on regulatory expectations and best practices for ancillary materials in the field of viral vector therapy. Stakeholder Liaison: Represent the company during interactions with regulatory bodies as needed, supporting customers in regulatory audits or inquiries. Fully remote opportunity Who you are Mimimum Qualifications: Bachelor\'s degree in a relevant scientific field (e.g., Biology, Biochemistry, Biotechnology, etc) Specialized regulatory training or certifications (e.g., RAC - Regulatory Affairs Certification) 3+ years of experience in regulatory affairs, preferably in the biopharmaceutical or cell and gene therapy industries
In-depth knowledge of FDA, EMA, and other global regulatory requirements for ancillary materials and viral vector production Strong understanding of GMP, IND filing processes, and commercial manufacturing considerations Experiece with regulatory agencies and authorities like the FDA or EMA Preferred Qualifications: Advanced degree preferred CMC experience preferred Exceptional communication and interpersonal skills, with the ability to explain complex regulatory concepts clearly and effectively to internal stakeholders, including R&D, quality assurance, and legal teams Ability to identify and manage risks associated with CGT products, particularly long-term safety and monitoring requirements. Understanding of adverse event reporting and pharmacovigilance as it pertains to CGT, including post-market surveillance. Experience working directly with CGT products, such as viral vector-based gene therapies, CAR-T therapies, or stem cell therapies Proven ability to work cross-f To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEyOTE2Ljg3NzBAZW1kbWlsbGlwb3JlY29tcC5hcGxpdHJhay5jb20 ** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEyOTE2Ljg3NzBAZW1kbWlsbGlwb3JlY29tcC5hcGxpdHJhay5jb20

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