Senior Manager, Promotional Regulatory Affairs

You need to sign in or
create an account to save a job.
Overview:Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities:The Senior Manager, Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals Global Regulatory Affairs Department and will be assuming a leadership role in the promotional materials review process and will provide insight, judgment and sound decisions on promotional programs and tactics for assigned products/teams under the guidance and direction of the Senior Director, Promotional Regulatory Affairs. Works collaboratively with Regulatory, Medical, Legal/Compliance and Commercial organizations. Develops and applies expertise to ensure promotional programs and tactics are compliant with regulations and company policies while supporting the achievement of business objectives.Essential Job Functions:Specific responsibilities will include:Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals. Under the direction of Sr. Director, Promotional Regulatory Affairs A, provides input on decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectivesProvide regulatory advice, and support to the organization. Lead the PMRC process and manage regulatory aspects of the review and approval for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to the Office of Prescription Drug Promotion (OPDP) in a timely fashion.Develop leadership skills and regulatory subject matter expertise to be able to grow into an independent leaderChair review meetings by leading discussion of the material being discussed and collaborating with other cross-functional reviewers to determine next steps and approval statusEnsure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures as well as FDA guidance and regulationsEffectively partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materialsWork closely with the Senior Director, Promotional Regulatory Affairs and other team members to develop regulatory subject matter expertise and leadership skillsProvide regulatory support for Medical Affairs Review Committee (MARC) and publications review Assist in development of regulatory strategy, guidance and expertise on new marketing concepts and promotional tactics for assigned product(s). Help manage interactions with FDA/OPDP for assigned product(s) including timely submission of materials for first use (FDA Form 2253 submission). Further develop depth and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Interprets and communicates FDA perspective to relevant stakeholders and recommends policy and/or process changes as needed, consulting with Regulatory colleagues as appropriateMinimum Requirements:B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree) and a minimum of 5 years of increasingly responsible experience in the pharmaceutical industry; direct experience in advertising and promotional material review (Regulatory or otherwise) is strongly preferred General understanding of FDA regulations and guidelinesStrong judgment and decision making skillsExcellent collaboration, verbal and written communication skillsJazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.