Job description

Job Responsibilities

• Plan, write, compile, and prepare documents for submission to FDA and international health authorities to support INDs, NDAs, BLAs, ANDAs, DMFs, design dossiers, amendments, supplements, briefing packages, annual reports, and related documents

• Identification and interpretation of US, EU and international requirements relating to biologic / medical device GMPs, CMCs, and quality system
• Monitor, prioritize, and supervise multiple regulatory projects at different stages of development to ensure required content of regulatory documentation is obtained
• Compile information into regulatory documents in consultation with subject matter experts
• Ensure technical accuracy and regulatory compliance of all submissions for assigned projects and ensure that applications are executed appropriately and submitted on time
• Provide input to development teams on development and CMC regulatory strategies to achieve development objectives
• Maintain well-organized RA records that allow ready retrieval of required information
• Assist with area SOPs and documentation creation / revisions
• Responsible for global product regulatory compliance, labeling, hazard communication and life cycle management support activities
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects

Qualifications

• At least one (1) year preparing regulatory submissions for pharma or biotech medical products with working knowledge of US and ICH requirements
• eCTD preparation and electronic submissions experience preferred
• Three (3) combined years of Regulatory Affairs, Manufacturing, Laboratory and/or Research and Development experience
• A Bachelor’s degree preferred within a scientific, technical or related discipline
• Project management experience preferred

Knowledge, skills & abilities

• Effective Organizational skills
• Excellent oral and written communication skills who actively listens, asks questions & advocates
• Demonstrates both creative and critical thinking skills
• High attention to detail and follow through
• Pro-active; high-performance and results orientation
• Able to manage multiple tasks, prioritize, and multitask as required

About Vascudyne

Headquartered in the heart of Medical Alley in Minnesota, Vascudyne is on a mission to improve patient care with regenerative biomaterials that are inspired by nature. Vascudyne, a privately held company founded in 2014, uses the TRUE™ Tissue technology to develop TRUE to Nature™ biomaterials for soft tissue repair and replacement. TRUE™ Tissue is developed from cells isolated from donor tissue and is 100% biological. There are no synthetic materials or chemical fixation used, and implanted tissues are completely cell-derived and acellular. The TRUE Tissue technology can be readily shaped into tubes, sheets, and other geometries making it suitable for many soft tissue applications, is mechanically comparable to native tissues, and is a ready to use, off-the-shelf allograft. Our team is growing, and we are looking for talented individuals passionate about regenerative medicine therapies. Vascudyne is proud to be an equal opportunity employer. For more information, please visit https://www.vascudyne.com/.

Employment Type

Full-time

Job Type: Full-time

Pay: $52,256.23 - $138,781.44 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Saint Paul, MN 55107: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Project management: 1 year (Preferred)
• preparing regulatory submissions for drugs or biologics: 1 year (Required)

Work Location: One location

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