Your Role:
The Director, Regulatory Affairs with CMC focus manages regulatory CMC activities for Miltenyi Biomedicine's cell therapy programs in the US, Canada, and other regions as applicable. This role partners with functional teams from Bioindustry and Biotec to develop and implement regulatory strategies that support clinical trials, health authority interactions, and product approvals. The Director provides strategic input on CMC requirements for advanced therapy products and supports regulatory submissions throughout the product lifecycle.
Essential Duties and Responsibilities:
- Develop and implement CMC regulatory strategies to support clinical development, marketing applications, and post-approval lifecycle management for cell and gene therapy products.
- Provide strategic regulatory guidance to cross-functional teams to align CMC development with regulatory expectations and business objectives.
- Lead the preparation, authorship, and review of CMC sections for INDs, CTAs, BLAs, and MAAs, including amendments and responses to health authority queries.
- Collaborate closely with process development, analytical development, regulatory operations, and external consultants to ensure timely delivery of CMC milestones, data packages, and submission-ready documentation.
- Oversee and provide regulatory input on process changes, comparability assessments, validation activities, and technical justifications to support manufacturing operations and regulatory submissions.
- Participate in change control evaluations to ensure proposed changes remain within regulatory compliance and align with registered dossiers.
- Support BLA/MAA CMC preparation activities and ensure readiness for regulatory interactions and marketing authorization.
- Represent Regulatory CMC in meetings with global health authorities, including preparation of briefing packages and participation in formal meetings.
- Identify, assess, and communicate CMC regulatory risks across programs and contribute to resolution and mitigation planning.
Requirements:
- Bachelor's degree in life sciences; advanced degree in health sciences preferred; At least 15 years of experience in the biotech/pharmaceutical industry.
- Extensive knowledge of GMPs and key requirements for CMC documentation for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics.
- Experience in cell and gene therapy CMC, late-stage development and commercial launch experience is mandatory.
- Experience in reviewing and writing CMC regulatory submission documents for global regulatory filings and related health authority interactions is preferred.
- 10 % travel.
Physical Demands:
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. The employee must occasionally lift and/or move up to 25 pounds. 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. Must be able to occasionally travel by car and plane.
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.
The hiring range for this position is expected to fall between $201,579 - $237,206/per year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.
In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.
