Regulatory Affairs Manager CMC
Intersect ENT is a global ear, nose and throat medical technology leader dedicated to transforming patient care through evidence-based innovation and an expanded portfolio that delivers solutions across the continuum of chronic rhinosinusitis disease space. In order to meet that goal, we hire people who like to challenge the status quo, collaborate cross-functionally, and pursue excellence.
Do you embody this spirit of innovation and collaboration? Are you ready to join our team?
PURPOSE OF JOB:
This role provides CMC Regulatory support for commercial and development projects. Coordinates and manages relevant submissions to US investigational new drug applications (IND), and new drug applications (NDAs). This role works closely with the Research & Development (R&D), Analytical Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs- Medical Device, and Quality Assurance departments, as well as with cross-functional project teams. Interfaces with Regulatory Agencies, such as FDA, Notified Body and competent authorities as required. Maintains regulatory correspondence and submissions/registrations. Maintains knowledge of US and international pharmaceutical and combination product regulations.
MAJOR DUTIES AND RESPONSIBILITIES:
- Participates in or leads cross-functional product development teams, development of regulatory strategies and support for Intersect ENTs clinical and non-clinical development programs, marketing applications and post-marketing activities.
- Responsible for regulatory project timelines and management of IND/NDA and global regulatory submissions.
- Lead regulatory activities including planning and reviewing of chemistry manufacturing and control (CMC) and nonclinical sections of regulatory submissions.
- Coordinate and prepare regulatory submissions (IND, NDA, 510k, PMA) to ensure compliance with FDA and international regulations and guidelines.
- Support IND and NDA applications including responsibility amendments, supplements, and annual reports.
- Provide global CMC regulatory guidance, especially as it pertains to current thinking related to combination drug/device products.
- Responsible for developing and maintaining department procedures with an emphasis on drug regulations.
- Provide proactive regulatory intelligence in areas of a competitive nature and maintains knowledge of changes in agency regulations and requirements (e.g. FDA, EMEA, ROW).
- Provide regulatory assessments for anticipated analytical, manufacturing and packaging Change Orders (CO).
- Other duties as needed.
- BS/BA degree in scientific discipline such as biology, chemistry, biochemistry, analytical chemistry, toxicology, biochemical engineering; MS/MA degree preferred.
- May require certification in assigned area.
- Minimum of 8 years’ experience in the pharmaceutical or biopharmaceutical/biotech industry.
- Minimum of 3 years’ experience in a Regulatory Affairs function.
- Has current knowledge of CMC-related guidelines from FDA, EMA, ICH, etc. and industry’s best practices. Must be detail oriented with well-developed organizational and analytical skills.
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
- Must have the ability to succeed in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.
PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS
Physical Activity – Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
Physical Requirements – Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Visual Acuity – The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Working Conditions – The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Intersect ENT (NASDAQ: XENT) is a medical technology company dedicated to advancing the treatment of ear, nose, and throat (ENT) conditions through evidence-based innovation. We provide treatments for people with chronic sinusitis, an inflammatory sinus condition that has been shown to substantially reduce quality of life. Sinusitis is one of the most common conditions in the United States.
Intersect ENT is an equal opportunity employer that strives to interview, hire, and promote a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.
Learn more here
Job posted: 2021-08-15