Radius Health, Inc. Senior Regulatory Coordinator – Strategy in New Jersey
Support regulatory affairs in formulation and execution of regulatory strategy and authoring of regulatory documents for submission to various Health Authorities. This includes providing support for all activities related to Health Authority meetings, requests for information and other queries from Health Authorities and other Regulatory Intelligence activities. This includes independently preparing and leading routine regulatory submissions.
Independently handle and prepare routine submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendments, and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations.
Contribute to Module #1 documents including FDA forms and cover letters for maintenance/non-maintenance submissions with management oversight.
Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities.
Research and present information regarding requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
2+ years’ experience within the pharmaceutical, biotechnology or device/diagnostics industry.
Bachelors/Masters preferably in a scientific or information technology field.
Proficient with relevant submission software, including but not limited to, Veeva Submissions, Adobe Acrobat, ISIToolbox, Microsoft Office, eCTD viewers.
Understand basic regulatory concepts
Highly organized and detail oriented.
Able to work independently.
Demonstrates ability to work with colleagues in an open, honest, and transparent manner leading to collaboration, respect, and trust.
The work is performed primarily in a remote office environment with occasional required in person office work, meetings, and/or travel. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee is required to utilize audio visual programs for frequent meetings and discussions with fellow employees, vendors, outside agencies and/or customers. The employee may lift and/or move up to 10 pounds occasionally.
Radius is a commercialized biopharmaceutical company committed to serving patients with unmet medical needs in endocrinology and other therapeutic areas. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases, initially targeting Prader-Willi syndrome.
Equal Opportunity Employer Statement
Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetics, or protected veteran status. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
External Company URL: http://www.radiuspharm.com/