Regulatory Affairs Associate - Biomedicine *PC 1222

Miltenyi Biotec; Waltham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Miltenyi Biotec seeks a Regulatory Affairs Associate in Waltham, MA, to develop regulatory strategies for pipeline products. The role involves compliance tasks, collaboration with cross-functional teams, and continual learning to adapt to changing regulations. Candidates must possess a Bachelor’s degree and relevant experience in Regulatory Affairs.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2-4 years of experience in Regulatory Affairs.
• Knowledge of regulatory requirements and guidelines.

Responsibilities

• Contribute to the creation of regulatory strategies for pipeline products.
• Prepare, review, and submit regulatory documentation.
• Maintain internal databases and tracking systems.

Skills

Attention to detail

Communication

Organizational skills

Adaptability

Proactive mindset

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

Regulatory Affairs Associate - Biomedicine *PC 1222

Pay Competitive

Location Waltham/Massachusetts

Employment type Full-Time

Job Description

Req#: REGUL002986

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Regulatory Affairs Associate - Biomedicine
Waltham, MA

Your Tasks:

The Regulatory Affairs Associate will work in close proximity with key leaders across various functional departments to actively contribute to the creation of regulatory strategies for the pipeline products.

Essential Duties and Responsibilities:

• The role works with and participates on multi-disciplinary matrixed project teams to support successful project deliverables while adhering to regulatory requirements for projects.
• Maintain and update internal databases and tracking systems to keep track of submissions, approvals, and other regulatory activities.
• Assist in the preparation, review, and submission of regulatory documentation to ensure compliance with relevant regulations and guidelines.
• Work cross-functionally with internal departments, including pre-clinical, clinical, quality, manufacturing, and third parties on Regulatory Affairs/Strategy related issues.
• Research and stay current on regulatory requirements, guidelines, and industry trends to support the development and implementation of regulatory strategies.
• Collaborate with cross-functional teams, including research and development, quality assurance, and manufacturing, to gather and compile necessary information for regulatory submissions.
• Support the Regulatory Affairs team in communication and correspondence with regulatory authorities and agencies.
• Assist in the preparation and maintenance of product labeling, packaging, and promotional materials in compliance with applicable regulations.
• Participate in continuous improvement initiatives within the Regulatory Affairs department and contribute to the development and updating of standard operating procedures (SOPs).
• Advise senior management of the impact the changing regulatory environment can/will have on the company's business and projects in the US.
• Perform other duties as assigned.

Requirements:

• Bachelor’s degree in Life Sciences or related field; A minimum of 2-4 years in Regulatory Affairs within the pharmaceutical or biotech industry. This experience should demonstrate knowledge of regulatory requirements and guidelines applicable to the assigned products; or an equivalent combination of education and experience.
• Remote/Flex
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

Skills:

• Strong attention to detail and excellent organizational skills.
• Effective communication and interpersonal skills, with the ability to work well in a team environment.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• A self-starter with a proactive mindset and eagerness to learn and grow in the field of Regulatory Affairs.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.

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, talk, and 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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

Miltenyi Biotec is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

Progress prospers with inspiration and curiosity. For 30 years Miltenyi Biotec has been developing products and services that are used in basic research, translational research and cell therapy. Today we are a team of more than 3,000 scientists, physicians, engineers, marketers and numerous other specialists.

At Miltenyi Biotec, innovative ideas are being turned into cutting edge products. Together, we are passionate about driving biomedical progress towards curing severe diseases.

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

Miltenyi Biotec, Inc. participates in E-Verify.

About the company

Miltenyi Biotec is a global biotechnology company headquartered near Cologne in Bergisch Gladbach, Germany.

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