The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Biologics, Biotechnology, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Our Senior Manager, Regulatory Affairs, will partner with our Advanced Wound Care business (biologics/pharma) to ensure efficient and effective regulatory review and risk assessment of promotional material for all segments and media (Print, broadcast and electronic), sales training, faculty training, Corporate Affairs communications, and any other materials required to be reviewed through PRC (promotional review committee). They will conduct reviews within established timelines and meet expedited requests as priorities and workload allow. There will be opportunity to get involved in innovative regulatory strategy development and implementation, including risk identification and contingency planning. Additionally, they will provide regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs as well as labeling. This is a highly visible role with a tremendous amount of cross functional collaboration with key stakeholders in areas such as Marketing, Medical Affairs and Legal.
Review and approve US and Global product and disease state materials/ communications to support corporate goals and comply with applicable laws, regulations, and guidance
Assist in all interactions with FDA Office of Prescription drug Promotion (OPDP) for assigned company products, help to maintain working relationship and effective communication with FDA reviewers, including pre-clearance of materials, as applicable. Responsible for compliance to FDA Form 2253 for promotional material submissions.
Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications. Provide stakeholders with updates on a regular basis as well as potential impact of enforcement activities. Provide training within the company as appropriate.
Provide support, develop and manage 3 direct report to ensure compliance and timely promotional material submissions, as well as other work related duties
Fort Worth, TX
Bachelor's degree in biological or health care scientific discipline
10+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 5 years of demonstrated experience in the review of device and prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
Understanding of the drug development process, including clinical trial design and labeling development process
Ability to excel in cross-functional settings and to manage multiple projects in a fast-paced environment
Exemplary compliance ethics and high concern for standards
The Person in this role must have excellent communication skills both verbal and written. All roles in US regulatory advertising and promotion require complete fluency in the English language as word choices and phraseology are particularly important in Rx drug promotion.
Experience with electronic review and approval programs
The physical demands described here are representative of those that must be met by an employee to successfully perform the essentials function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires sitting, talking or listening, more than 2/3 of the time. Walking or standing less than 1/3 of the time. Use of hands to use computer or write documents less than 2/3 of the time. Ability to travel by air and motor vehicle both domestically and internationally may be required. Some overnight travel required. Searching for, lifting and carrying records weighing up to 25 pounds less than 1/3 of the time. Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time.
Internal Number: R44866
About Smith & Nephew
At Smith+Nephew, we design and make technology that takes the limits off living, and we help healthcare professionals achieve the same goal. Together we improve life, while also improving performance.
Life Unlimited. Smith+Nephew exists to restore people’s bodies and their self-belief.
Our global franchise areas include:
Orthopaedics includes an innovative range of Hip and Knee Implants used to replace diseased, damaged or worn joints, robotics-assisted enabling technologies that empower surgeons, and Trauma products used to stabilise severe fractures and correct bone deformities.
Sports Medicine & ENT
Our Sports Medicine and Ear, Nose and Throat (ENT) businesses offer advanced products and instruments used to repair or remove soft tissue. They operate in growing markets where unmet clinical needs provide opportunities for procedural and technological innovation.
Advanced Wound Management
Our Advanced Wound Management portfolio provides a comprehensive set of products to meet broad and complex clinical needs, to help healthcare professionals get CLOSER TO ZERO human and economic consequences of wounds