Sr. Manager, Regulatory Affairs, Promotion

2 weeks ago

Morristown, United States Pharmacosmos Therapeutics Inc Full time

Pharmacosmos Therapeutics Inc., an affiliate of Pharmacosmos, markets Monoferric in the US high-dose IV iron market. Pharmacosmos Therapeutics brings together: A best-in-class product Resources required to drive rapid growth An ability to adapt quickly to market change A new standard for patient care Founded in 1965, Pharmacosmos is headquartered in Denmark. We are a family-held company built on passionate and knowledgeable people. We value integrity, open-mindedness, and respect. These values guide us in our endeavors and touch everyone in every part of our journey. We respect everyone who becomes a part of our journey. As a company, we strive to become the world leader in the treatment of iron deficiency anemia, one of the largest global health issues, and aspire to change the way iron deficiency anemia is treated. Pharmacosmos is focused on three business areas: branded pharmaceuticals, APIs, and carbohydrates. The US company focuses primarily on the prescription iron pharmaceutical market. Two-thirds of its revenue comes from this segment of the business. Pharmaceutical grade carbohydrates and API enhance their supply chain capabilities and overall market strategy and positioning. The company takes pride in our robust research and development program with a focus on human and veterinary medicines. Pharmacosmos cultivates a collaborative, performance-based culture. We recognize and reward employees for the value they bring and empower them to do meaningful work. Built upon the heritage and financial strength of the parent company, Pharmacosmos Therapeutics benefits from a singular focus, driving the growth of Monoferric. Job Purpose: The Sr. Manager, Regulatory Affairs, Promotion & Labeling will conduct the matrix review of advertising, promotional (and non-promotional), communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. This role ensures compliance with FDA regulations, company policies, and industry guidelines. The Sr. Manager will work closely with cross-functional teams to support the development and implementation of regulatory strategies and FDA submissions for promotional materials. Responsibilities: Serve as the lead regulatory reviewer on the Material Review Committee (MRC) and Medical Content Council Committee (MCCC) for product promotion, labeling, core sales training materials, and other promotional and non-promotional communications, including social media, press releases, and talking points. Provide regulatory expertise towards the development of optimal labeling, including new and supplemental new drug applications. Coordinate all aspects of regulatory submissions related to promotional materials. Ensure regulatory compliance while effectively managing business risks through identifying various strategies for addressing business objectives, advising on risk/benefit towards assisting clients with making informed business decisions with a clear understanding of the regulatory framework. Monitor and interpret FDA regulations and guidelines, including FDA warning and untitled letters, relevant to drug promotion and advertising. Ensure that changes in US Prescribing Information are reflected in current promotion and advertising materials. Develop and implement regulatory training programs for cross-functional partners. Provide guidance and feedback to internal PTI constituencies (e.g., Sales, Medical, Market Access) to ensure that promotional and non-promotional practices align with regulatory guidelines and support business objectives. Other duties as assigned. Education and Professional Background: Bachelor’s degree in a scientific or related field is required; an advanced degree (e.g., MS, PharmD, PhD) is preferred. Successful track record with 3-5+ years of experience in regulatory affairs, specifically in advertising and promotion review, with a pharmaceutical/biotechnology company. Excellent understanding of US regulations for drug promotion/advertising and labeling. Experience in leading regulatory activities for promotional OPDP submissions (including pre-clearance and 2253 “time of first use” submissions). Must possess strong problem-solving, negotiation, and decision-making skills. Excellent interpersonal and communication skills. Self-motivated with the ability to work independently and as part of a cross-functional group. Competencies: Attention to Detail: Ensures accuracy and consistency in regulatory submissions and reviews. Regulatory Knowledge: Deep understanding of FDA regulations and related guidance. Strategic Thinking: Develops regulatory strategies aligned with informed business objectives. Communication Skills: Clearly articulates regulatory requirements and strategies. Collaboration: Works effectively with cross-functional teams. Attitude and Demeanor: Proud Pharmacosmos ambassador. Strong personal leadership and initiative. Collaborative and team-oriented approach. High ethical standards and professionalism. Ability to manage multiple tasks and prioritize effectively. Strong problem-solving skills and analytical thinking. Flexibility: Our roles can evolve over time. Reasonable flexibility is, therefore, a key part of any job at Pharmacosmos. Significant variations in duties and responsibilities should be discussed between the employee and manager. Additional information: Requires budgetary responsibilities and discretion with confidential data. Traveling – approximately 5% of the time. All job requirements listed indicate the minimum level of knowledge, skills and/or experience necessary to perform the job proficiently. This job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Employees will be required to perform any other job-related duties as requested by their supervisor, subject to reasonable accommodation. Pharmacosmos Therapeutics Inc. is committed to equal opportunity in employment. We value diversity which embraces all perspectives towards innovation and are committed to making PTI a truly inclusive place to work where everyone of us can be our best and true selves. We select and employ qualified candidates in accordance with their competencies and skills to perform the duties of the job regardless of gender, gender identity or expression, ancestry, national or ethnic origin, marital status, race, religion, color, age, disability, sexual orientation, military, or veteran status. #LI-Remote #J-18808-Ljbffr

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