Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
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.
Learn More About RegulatoryOne 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.
Follow the CodeYour membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Get StartedLike 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.
LEARN MOREJoin 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.
LEARN MOREFor 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
BUY NOWThere are hundreds of RAC testing centers available worldwide. Either RAC exam (Devices and Drugs) may be taken at any location. Find an upcoming exam at a location near you.
VIEW SCHEDULE Pharmacosmos Therapeutics Inc.Pharmacosmos Therapeutics Inc., a newly formed affiliate of Pharmacosmos, has been established to commercialize Monoferric® in the rapidly growing US high-dose IV iron market. Structured to be agile and fast-moving, Pharmacosmos Therapeutics will bring together a best-in-class product, the resources required to drive rapid growth, and an experienced, high-performing team with the shared purpose of establishing a new standard of care for patients in need of high-dose IV iron. The company is creating a collaborative, performance-based culture in which employees are recognized and rewarded for the value they bring to the organization and empowered to do meaningful work. Built upon the heritage and financial strength of the parent company, Pharmacosmos Therapeutics has the benefit of singular focus with all efforts directed toward the shared objective of driving the growth of Monoferric®. Pharmacosmos Therapeutics is based in Morristown, New Jersey. Parent Company: PharmacosmosPharmacosmos was founded in 1965 and is headquartered in Denmark; it is a family-owned, fully integrated commercial stage company specializing in iron therapy, committed to becoming the world-leader in the treatment of iron deficiency with or without anemia. Today, more than 1 billion people globally live with iron deficiency anemia, representing one of the largest global health issues. Pharmacosmos aspires to change the way iron deficiency is prevented and treated. Built upon a manufacturing foundation, Pharmacosmos has three business areas: branded pharmaceuticals, APIs and carbohydrates. The company’s primary focus is the prescription iron pharmaceutical market, with two-thirds of revenue derived from this segment of the business. The human iron focus is strengthened and supported by their ability to produce pharmaceutical grade carbohydrates and API which enhances their supply chain capabilities and overall market strategy and positioning. Additionally, the company has a robust research and development program focused on human and veterinary medicines. The Manager/Senior Manager, Regulatory Affairs, Advertising & Promotion will provide regulatory advice on all Regulatory matters regarding Pharmacosmos products, including the review of advertising and promotion materials, in accordance with business goals and objectives, FDA regulations/ guidance, PhRMA guidelines, and company policy. Responsible for writing, reviewing and approving all regulatory filings to the FDA regarding Pharmacosmos products marketed in the US. Responsible for reviewing and approving US advertising and promotional materials as well as sales training materials for prescription drugs for compliance with the letter and spirit of FDA regulations and our company policies and standards. Represents Regulatory Affairs on the company’s Materials Review Committee (“MRC”). Prepares promotional materials for submission to the FDA in a timely manner and in accordance with FDA regulations. Works collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives, and communicates significant changes in FDA perspective to relevant stakeholders.
The Manager/Senior Manager Regulatory Affairs, Advertising and Promotion reports to the Head of Scientific Affairs at PTI.
|
Qualifications
Confidential Data: Yes Budgetary Responsibility: Yes Travel Requirements: 10% |