Director, Regulatory Affairs Advertising & Promotion

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

The Director, Regulatory Affairs Advertising and Promotion will have accountability for review and approval of U.S. promotional and non-promotional communications and for leading interactions with the FDA Office of Product and Drug Promotion (OPDP) for assigned product(s).

The Director’s responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the applicable Sobi Review Committee (RC) process enabling business needs to be met in a compliant, compelling, and timely way. This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing commercial regulatory advice and guidance through the product life-cycle assuring conformity with applicable laws, regulations and Sobi policies.

This position is remote, but candidates must live on the US East Coast. #LI-remote

Key Responsibilities

• Serve as an internal subject matter expert on FDA Advertising & Promotion issues, including scientific exchange, for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional and non-promotional materials to maintain compliance with applicable regulations
• Provide regulatory training as needed on applicable laws, regulations and Sobi policies, and leadership on assigned RC with respect to best practices in compliance with company policies and guidelines for RC processes. Demonstrate leadership as the regulatory reviewer on RC(s)
• Manage interactions with OPDP/APLB, including response to regulatory inquiries, and as needed, discussion with OPDP/APLB staff
• Foster a healthy business partnership environment with stakeholders to ensure company meets strategic business objectives
• Partner with RC teams in the management of tasks that help support compliant execution of tactics and programs through the product’s life-cycle

Experience

• Minimum of 10 years of experience in pharmaceutical industry and a minimum of 5years as a Regulatory Ad & Promo professional
• Experience in Rare Diseases; Hematology and/or Oncology a plus
• Advanced knowledge of U.S. advertising promotion regulations and scientific exchange provisions with proficient technical knowledge in aspects of drug development and labelling
• Advanced experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters
• Experience with international regulatory advertising and promotion regulations and processes a plus but not required

Core Competencies

• Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product and therapeutic knowledge as well as evidentiary standards required to support product claims
• Apply advanced regulatory experience and business knowledge in the development of new ideas and best practices that support Sobi
• Advanced ability to spot issues and convey facts and risk mitigation strategies and guidance, including impact to Sobi without sufficient risk mitigation
• Demonstrate understanding of company objectives while executing regulatory strategies that deliver compliant, compelling, and timely work product
• Must reasonably foresee situations that are likely to be vague or challenging, and strategize to prevent or mitigate negative impact
• Demonstrate the ability to build agreement and acceptance through the ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively
• Efficiently and systematically plan, prioritize, and execute individual work, team work, and projects while balancing quality, risk, and benefits

The base salary pay range for this role is $170,000-$220,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

Personal attributes

• We are seeking an individual who is an influential communicator, independent, proactive, and dynamic
• You must possess the ability to adapt and tailor your com