Sr Director, Regulatory Affairs CMC *PC 1626

Miltenyi Biomedicine; Washington, Baltimore (District of Columbia, MD); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Job summary

Miltenyi Biomedicine is seeking a global CMC Regulatory Affairs leader to steer regulatory strategies for CGT products from development through commercialization. You will mentor a team, review submissions, and guide manufacturing, analytical methods, and lifecycle management in collaboration with cross-functional partners.

The role emphasizes leading regulatory strategy, coordinating with FDA/EMA, and ensuring compliance across global programs.

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline; 12+ years demonstrated hands-on expertise in CMC Regulatory Affairs for CGT products is mandatory.
• Extensive experience in Regulatory Affairs within biotechnology and/or pharmaceutical environments.
• Proven experience supporting global regulatory submissions and interactions with health authorities, in particular in Europe and US.

Responsibilities

• Coach mentor and lead global CMC RA manager who will lead global CMC regulatory strategies for CGT products throughout development and commercialization.
• Oversee and develop strategy and review and approve CMC sections for regulatory submissions including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations.
• Oversee and provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies.
• Oversee and assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide.
• Support interactions with global health authorities including FDA, EMA, MHRA and other agencies.
• Collaborate closely with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions.
• Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies.
• Drive regulatory risk assessments and mitigation plans across the product lifecycle.

Skills

CMC regulatory leadership

Regulatory strategy

Interaction with health authorities

English fluency

Project management

Leadership

Education

Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline

Job description

Your Role:

The role will lead the team of global CMC RA managers and as the global regulatory expert for Chemistry, Manufacturing & Controls (CMC) activities supporting our Cell & Gene Therapy (CGT) portfolio. The role will oversee and provide strategic regulatory leadership across development, registration and lifecycle management while ensuring compliance with global regulatory requirements.

Essential Details and Responsibilities:

• Coach mentor and lead global CMC RA manager who will lead global CMC regulatory strategies for Cell & Gene Therapy products throughout development and commercialization as part of the overall global regulatory strategy for each product / compound.
• Oversee and develop strategy and review and approve CMC sections for regulatory submissions including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations.
• Oversee and provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies.
• Oversee and assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide.
• Support interactions with global health authorities including FDA, EMA, MHRA and other agencies in collaboration with local RA representatives.
• Collaborate closely with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions.
• Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies.
• Drive regulatory risk assessments and mitigation plans across the product lifecycle.

Requirements:

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline; +12 years demonstrated hands-on expertise in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory.
• Extensive experience in Regulatory Affairs within biotechnology and/or pharmaceutical environments.
• Proven experience supporting global regulatory submissions and interactions with health authorities, in particular in Europe and US.
• Deep understanding of biologics, ATMPs, Cell & Gene Therapy products and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent English written and verbal communication skills.

Candidates should possess substantial regulatory affairs strategy and submissions experience in one or more of the following areas:

• Cell therapies
• Gene therapies
• Viral vectors
• Advanced Therapy Medicinal Products (ATMPs)
• Biological product development and Manufacturing

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 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.

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 $249,995 - $272,020/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.

Benefits:

• 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.

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

Miltenyi Biotec participates in E-Verify.

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.