Director Promotional Regulatory Affairs

Company: Jazz Pharma
Location: Palo Alto
Posted on: April 10, 2021

Job Description:

Overview:

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

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 Director, Promotional Regulatory Affairs (PRA) will be a member of Jazz Pharmaceuticals' Global Medical Affairs Department and will be responsible for leading the promotional materials review process and providing 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. Will provide senior PRA leadership to medical, legal, compliance and commercial organizations and applies expertise and organizational influence to ensure development of promotional programs and tactics that are compliant with regulations and company policies while supporting the achievement of business objectives.

Essential Job Functions:

Specific responsibilities will include:

Specific responsibilities will include:

Provide PRA leadership at the business unit level with the potential to manage/mentor direct report(s)

Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals. Under the direction of the US lead Promotional Regulatory Affairs, 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

Serve as the Promotional Regulatory Affairs lead for a new product launch(es) through contributions to the US Core launch team for assigned product(s)

o 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.

o Further develop independent leadership skills and regulatory subject matter expertise

o Chair review meetings by leading discussion of the material being discussed and collaborating with other cross-functional reviewers to determine next steps and approval status

o Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures as well as FDA guidance and regulations

o 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

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

Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review

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

Provide guidance and expertise on new marketing concepts and promotional tactics for assigned product(s).

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. A minimum of eight years pharmaceutical industry experience with at least 5 years' experience in regulatory affairs advertising and promotion

Experience with 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.

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