Regulatory Affairs Manager * PC 953

Your Tasks:

As part of the Miltenyi team, you will collaborate with key functional leaders to formulate regulatory CMC strategies. This role will spearhead regulatory CMC activities for Miltenyi BioMedicine in the US, Canada, and potentially other regions. They will represent regulatory CMC in matrix teams dedicated to cell therapy pipeline or commercial products throughout their entire lifecycle, with a focus on research-driven projects. Furthermore, they will independently offer strategic guidance on current regulatory CMC standards and expectations for marketing applications and clinical trial projects.

Essential Duties and Responsibilities:

• Draft CMC sections for both US and international regulatory submissions (IND/IMPD, BLA/MAA) and address responses to regulatory inquiries.
• Evaluate change controls and provide regulatory assessments. Skillfully interpret and communicate data.
• Collaborate with internal departments such as R&D, preclinical, clinical, quality, and manufacturing, as well as third parties on Regulatory CMC issues. Engage closely with Analytical Development and Regulatory teams to craft project plans and ensure timely achievement of CMC milestones.
• Relay regulatory CMC updates, expectations, and decisions to both internal and external stakeholders, including CROs, consultants, and contractors. Design and execute effective CMC issue resolution strategies.
• Present operational strategies, scientific data, and CMC approaches to a range of audiences, from regulators to executives.
• Oversee CMC deliverables, including process modifications, comparability evaluations, process validation, and regulatory submissions. Provide SME support for operations.
• Recognize and evaluate regulatory risks in projects or programs and act as a technical guide within the discipline.
• Brief senior management on potential implications of evolving regulatory landscapes in the US on company operations and projects.

Requirements:

• Degree in chemistry or related discipline over 3 years of industry experience in cell therapy manufacturing process development and documentation.
• Well-acquainted with contemporary analytical methods used in pharmaceutical analysis and has a comprehensive grasp of cGMPs, ICH guidelines, industry best practices, and compendia.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Generally, this job is performed in an office environment.

Miltenyi Biomedicine, Inc. is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

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