Regulatory Affairs Specialist

Company Description AgNovos is a biotechnology company that develops new treatments leveraging regenerative medicine to address persistent unmet medical needs related to bone disease. The Company was founded by Dr. James Howe, a renowned orthopedic surgeon who worked in clinical practice and research for more than thirty years. The first therapeutic area that we are addressing is osteoporosis, a condition afflicting millions of people, especially women. The disease is characterized by lost bone volume and quality, reduced bone strength and increased fracture risk. In response to what many experts consider an osteoporosis crisis, AgNovos is working to transform the landscape of bone health. AgNovos is headquartered in Rockville, MD and has a corporate office in New York City. Job Description You will primarily assist in the preparation of regulatory submissions for AgNovos' lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall regulatory support, including but not limited to FDA meeting preparations, archiving documentation, making entries into and maintaining the regulatory database and file storage system. Additional responsibilities may include regulatory support for Manufacturing/Operations and Quality Assurance primarily in the area of regulatory compliance, document and records management. A successful individual in this role will need to be highly organized with attention to details. Essential Duties and Responsibilities: Coordinate and provide regulatory support for international regulatory submissions and FDA submissions (e.g., IDE and PMA). Responsibilities including but not limited to proofread and format documentation, follow up closely on internal review process and compile updated document based on feedback, ensure accuracy and consistency of documents intended for submissions, etc. Maintain and update Technical Files and Design Dossiers upon request to ensure compliance with current regulatory and company standards Coordinate and prepare materials and presentations for internal meetings and FDA meetings, utilizing Microsoft Office Suite tools Maintain tracking tools for all regulatory submissions, communications and documentation Maintain and update the regulatory synopses for all regions Provide support to the Quality Assurance department for document control, audits, complaint handling, and CAPAs Track reporting requirements and filing deadlines and keep the team informed Coordinate with Manufacturing/Operations and complete regulatory requirements for Import/Export/Customs Review regulations and guidance to keep apprised of regulatory changes and new regulatory developments Demonstrate ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position Additional projects as assigned Qualifications BS/BA degree required in science/health-related field Six years hands-on experience performing Regulatory Affairs support activities Skilled at managing cross-functional regulatory projects Ability to read, analyze, and interpret professional journals, technical procedures, SOPs, guidance, standards, and regulations Ability to learn and understand scientific and technical aspects of Class II and III medical devices Experience with regulatory submissions in the US and EU: 510(K), PMA, and CE Technical Files/Design Dossier preferred Reliable and excellent attention to detail Excellent oral and written communication skills Highly collaborative and works effectively in teams Highly organized with the ability to meet deadlines, and be flexible to changing priorities Demonstrates good documentation practice including but not limited to - proof reading, formatting, indexing, record keeping, etc. Excellent computer skills, with a focused proficiency in MS Office and Adobe Acrobat Ability to work with minimum supervision and thrive under pressure Demonstrates analytical and problem-solving skills Additional Information Physical Requirements: While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds Specific vision abilities required by this job include close vision, distance vision Office-based environment While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job. All your information will be kept confidential according to EEO guidelines. Compensation & Benefits: The annual salary range for this position is $90k- $110k. Final salary will be determined based on several factors including market analysis, experience and internal equity. AgNovos Bioscience offers a comprehensive suite of benefits including medical, dental, and vision coverage to a 401(k) plan with company match. This position is on a hybrid schedule, with the candidate expected to work in the Rockville office 3 days per week.

Created: 2024-11-05