Sr. Regulatory Affairs Specialist I *PC 828

Your Tasks:

Responsible for developing and executing company regulatory objectives to ensure harmonization with worldwide regulatory requirements by developing assigned regulatory aspects for product pre- approval and post-marketing compliance.

Essential Duties and Responsibilities:

• Initiate and manage regulatory filings associated with company sponsored registration trials with minimal supervision.
• Independently manage timelines of assigned projects in accordance with established regulatory goals.
• Write, review, coordinate and compile submissions to US FDA and Canadian Health Authorities, while maintaining accuracy and consistency across jurisdictions with minimal assistance.
• Promote corporate awareness of CMC requirements, GMP requirements, and industry trends.
• Develop and recommend strategies to expedite Master File submissions and regulatory approvals.
• Review internal documentation including SOPs, material specifications and stability protocols.
• Maintain regulatory SOPs and creates new processes and policies as needed.
• Evaluate the regulatory impact of GMP compliance and validation issues.
• Independently review manufacturing changes for change control and associated regulatory risk assessments and communicates findings directly to other departments on behalf of Regulatory Affairs.
• Develop and contribute to RA process improvements to increase efficiency and accuracy of submissions to the FDA.
• Cross train staff and provides onboarding assistance for new hires as needed to maximize resources within the department.
• Independently represent the company to customers and outside agencies including the FDA.
• Participate in developmental plan meetings.
• Attend scientific and/or regulatory conferences and develop and cultivate positive relationships.
• Ensure quality and accuracy of documents.
• Other duties may be assigned.

Requirements:

• Bachelor's degree concentrating on Biotechnology or Pharmaceutical Studies; 5-8 years related experience and/or training.
• Must possess a proven track record of successful regulatory submissions and positive relationships with regulatory personnel.
• Must possess an in-depth knowledge of submission requirements and guidelines including INDs, IDEs, HDEs, NDAs, BLAs and PMAs. Must have the ability to correctly interpret and apply international regulations.

Skills:

• Ability to operate a computer with Windows operating system, Outlook email, internet, databases, and basic MS Office products.

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 $119,973/per year-141,135.75/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.

Miltenyi Biotec North America is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec North America participates in E-Verify.

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.