Senior Manager, Promotional Regulatory Affairs

The Senior Manager, 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 process; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products/teams.

The Senior Manager works 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.

Specific responsibilities will include:

• Under limited supervision from the GMPRA head or delegate, 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

• Provides regulatory advice, and support to the organization 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.

• Develops leadership skills and regulatory subject matter expertise to be able to grow into an independent leader

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

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

• Provides regulatory support and advice for Medical Affairs Review Committee (MARC)

• Assists in development of regulatory strategy, guidance and expertise on new marketing concepts and promotional tactics for assigned product(s).

• Effectively presents pertinent information to appropriate cross-functional groups.

• Compellingly presents position statements and rational for decisions to GMPRA leader and as needed to Regulatory, Medical and Commercial functions.

• Helps manage interactions with FDA/OPDP for assigned product(s) including submission of materials for advisory comments.

• Further develops 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

Minimum Requirements

• B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree), relevant master's degree (Pharmacy, advanced scientific or law)

• Substantial 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 guidelines

• Strong judgment and decision-making skills

• Excellent collaboration, verbal and written communication skills