Intersect ENT, Inc. (www.intersectent.com) is a fast growing, well-funded, early commercial stage medical device company seeking enthusiastic, entrepreneurial, and talented people to continue building a great company. Our mission is to provide physicians the ability to solve multiple clinical challenges with targeted solutions by combining medical and mechanical therapy. Approved by the FDA and now in the market, our product is a dissolvable drug-eluting implant that props open the sinus cavity and allows for localized delivery of steroid directly to the sinus mucosa for patients with chronic sinusitis, a condition that affects one out of seven adults in the U.S. For patients, this may mean less invasive treatment options, improved outcomes, and reduced need for systemic drugs which can lead to serious side effects.
Intersect ENT has been recognized by FierceMedicalDevices as one of the 2013 Fierce 15, designating it as one of the most promising private medical device and diagnostics companies in the world.
Were looking for an experienced Regulatory Affairs Manager to plan and implement global regulatory strategies for our drug/device combination products, taking them from development through marketing approval. The qualified individual will be responsible for providing regulatory leadership in the support of IND/NDA and international regulatory applications and ensuring compliance to all applicable regulations and standards.
DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
EDUCATION / EXPERIENCE REQUIREMENTS:
- Regulatory representation and leadership to 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 project timelines and management of IND/NDA and global regulatory submissions.
- Lead regulatory activities including planning and reviewing of chemistry, manufacturing and control and nonclinical sections of regulatory submissions.
- Coordinate and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines.
- Support IND application including responsibility for safety reporting requirements, 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 SOPs with an emphasis on drug regulations.
- Responsible for management of facility registration and drug listings
- Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations.
- Accountable for successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects.
- Participate with all disciplines within the organization to obtain and/or provide information for regulatory filings.
- Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements (e.g. FDA, EMEA).
- Maintain well-organized, auditable regulatory files.
- Provide regulatory support for quality assurance and regulatory compliance activities.
- Provide regulatory guidance regarding analytical methods and requirements pertaining to combination products.
- Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
- Represent RA functional area in the review and approval of Engineering Change Orders (ECO).
- Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials.
- Minimum of BS in life sciences, engineering, or equivalent required.
- Minimum six years experience in regulatory affairs medical device/biopharmaceutical industry.
- Regulatory submission project management experience required.
- Experience in developing, writing and submitting successful IND/NDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines.
- Excellent verbal and written communication skills.
Qualified candidates only. Please submit your resume and
- Experience with submitting documents in CTD and eCTD format.
- Must be detail oriented with well-developed organizational and analytical skills.
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
- Must enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.
salary requirements to email@example.com.
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. We believe in the importance of hiring the finest qualified people, and to that end, and being mindful of our responsibilities to our employees and customers, all offers of employment are contingent upon the results of a confidential pre-employment background check.
- 18 months ago - save job