Director, Global Medical and Promotional Regulatory Affairs

Job Description

If you are a current Jazz employee please apply via the Internal Career site.

\n

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and their families. We are dedicated to developing \nlife-changing medicines for people with serious diseases — often with limited or no \ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. Please visit\nwww.jazzpharmaceuticals.com\nfor more information.

\n

THIS IS A REMOTE BASED OPPORTUNITY IN THE UNITED STATES

The Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group and will be assuming a leadership role in the promotional materials review; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The Director works autonomously and collaboratively with Regulatory, Medical, Legal / Compliance and Commercial organizations. The individual 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 :

Lead the promotional material review committee (PMRC) for assigned products / therapeutic areas in the US for Jazz Pharmaceuticals.

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 objectives

Presents clear position statement and risk analysis to leaders in the regulatory department, medical affairs and other departments as needed

Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product in oncology.

Provide 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.

Effectively partner with Regulatory colleagues, Medical Affairs, Legal / Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materials

Exercise independent leadership skills and regulatory subject matter expertise

Work closely with the Promotional Regulatory Affairs lead and other team members to develop regulatory subject matter expertise and leadership skills

Provide regulatory support for Medical Affairs Review Committee (MARC)

Contribute to the development of regulatory strategy through assigned Global Regulatory team

Lead interactions with FDA / OPDP for assigned product(s) including submission of materials for advisory comments for full approval and accelerated approval products.

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 appropriate

Required / Preferred Education and Licenses :

B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree).

Advanced degree in a scientific discipline (e.g. PharmD) strongly preferred.

Substantial pharmaceutical industry experience with proven experience in regulatory affairs advertising and promotion

Experience with Oncology and new product launch support is strongly preferred

Strong understanding of FDA regulations and guidelines

Strong judgment and decision-making skills

Excellent collaboration, verbal and written communication skills

Jazz 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.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is : $188,800.00 - $283,200.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here :