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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: Pharmacosmos
Pharmacosmos 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 anaemia. Today, more than 1 billion people globally live with iron deficiency anaemia, 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 Director, Regulatory Affairs, Advertising & Promotion functions independently to provide strategic 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.
Heads the Regulatory Affairs function at Pharmacosmos Therapeutics Inc.
Authors and reviews NDA Annual Reports, Product, and Establishment registrations, USPI revisions in collaboration with other functions, and other regulatory communications
Serves as a primary regulatory advertising and promotion reviewer on the Materials Review Committee (“MRC”)
Actively contribute to the development and implementation of regulatory strategy for promotional labeling, core sales training materials, and other communications including social media, press releases, and talking points
Coordinate all aspects of AP regulatory submissions including promotional materials
Ensures regulatory compliance while effectively managing business risks
Understands global promotional strategies and provides solutions to local US regulatory promotional issues
Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted, and prepares complaint letters to OPDP if needed
Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled, and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings
Ensures that changes in US Prescribing Information are reflected in current promotions and advertising
Actively contributes to the development and implementation of regulatory training programs for cross-functional partners
Leads Regulatory Inspection Readiness initiative and is main Regulatory contact in case of an inspection
The Director Regulatory Affairs, Advertising and Promotion reports to the Head of Scientific Affairs at PTI.
MA/MS Degree required
Advanced degree preferable (MD, PhD, PharmD, or JD)
Minimum 8+ years Pharmaceutical/Biotechnology industry experience, 6+ years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs
Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP
Experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, “time of first use” submissions)
Experience with regulatory activities involved with a marketed product
Experience with FDA and/or other Health Authority inspections is a plus
Strong understanding of medical terminology, as well as understanding of business goals of the involved business franchise, marketing concepts and tools
Must perform independently with strong problem solving, negotiation and decision-making skills
Must possess strong interpersonal and communication skills, as well as effective cross-cultural awareness and sensitivity for a multicultural/multinational environment
Self-motivation and the ability to work as a collaborative team member are essential
Confidential Data: Yes
Budgetary Responsibility: Yes
Travel Requirements: 10%
Internal Number: 1
About Pharmacosmos Therapeutics Inc.
Pharmacosmos Therapeutics Inc., the US affiliate of Pharmacosmos, 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. Pharmacosmos Therapeutics Inc. is located in Morristown, NJ. Pharmacosmos, an international company headquartered in Denmark, is considered a world leading authority in treatment of iron deficiency anemia. Pharmacosmos is family-owned with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments for human and animal use. A research-based company, its ongoing R&D program focuses on improving the lives of patients with iron deficiency anemia. In the 2016 Global Burden of Disease study1, Iron Deficiency Anemia was ranked as one of the ten most prevalent global conditions with an estimated 1.24 billion conditions reported. Pharmacosmos has affiliates in the US, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries across the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency. For more information about Pharmacosmos, visit www.pharmacosmos.com.