Regulatory Compliance Director

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The Position

The Opportunity

The Regulatory Compliance Director is a people leader role. Primary responsibilities include leading a team of high performing regulatory compliance professionals and managing FDA regulatory matters concerning advertising and promotional activities. The role requires broad expert knowledge and experience in analyzing and assessing FDA regulatory requirements in the context of business strategy and initiatives. The ideal candidate will collaborate with cross-functional teams, including marketing, medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter squads, taking a leading role in navigating complex situations within the quality and regulatory compliance landscape to deliver solutions that enable the business to meet customer/patient needs and FDA regulatory requirements. 

Primary Responsibilities:

• Develop and implement regulatory strategies for advertising and promotional materials to ensure compliance with FDA regulations and other applicable guidelines.

• Assess the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives.

• Work collaboratively throughout the organization in a leadership, advisory, and facilitative capacity utilizing interdepartmental teams and systems to achieve compliance, quality improvement and risk management goals and objectives.

• Develop an in-depth working knowledge of the products, pipeline, market and business model and apply this knowledge in managing direct reports and in the delivery of sound and practical counsel and advice focused on regulatory compliance.

• Partner with Roche’s sales, marketing, and other commercial teams, to develop and implement the effective sale, distribution, marketing and advertising of Roche’s product portfolio in the U.S. by providing well-reasoned legal advice and practical and creative solutions to complex regulatory issues in support of business objectives.

• Collaborate with, support and provide regulatory guidance and expertise to Roche business stakeholders in the assessment and implementation of third-party collaborations and partnering.

• Collaborate with the RDC US Chief Compliance Officer to support Roche’s compliance programs.

• Support and enable company compliance with policies, procedures, and code of conduct.

• Recruit, develop, support and manage a team of high performing regulatory compliance professionals and provide guidance and coaching in developing the team’s skills and knowledge.

• Sponsor and support various team projects and initiatives, including making continuous improvements to commercial processes and liaising with business partners to assist in creating or improving relevant policies.

• Help set priorities for the Roche US Commercial Affiliate Legal & Compliance department and actively engage as an advisor and leader within the department and across the organization.

Who You Are

• Education: Doctor of Jurisprudence from an ABA-accredited law school, licensed to practice law in one or more of the 50 states. 

• Professional experience: Preferably, at least 8-10 years’ experience practicing law at a large- to medium-sized law firm or within a corporate law department; practice should include areas of specialization in FDA regulatory law, with a focus on advertising and promotion. Substantial industry experience also considered.

• Strongly Preferred Skills/Expertise:

  • In-depth knowledge of FDA regulations and familiarity with FTC regulations related to advertising and promotion.

  • Demonstrated experience in medical device advertising and industry best practices with deep understanding of regulatory frameworks that affect medical device advertising and marketing.

  • Experience reviewing and providing compliance counsel on advertising, marketing, and/or promotion for prescription drugs, biologics, or medical devices.

  • Strong understanding of the regulatory landscape and the ability to provide strategic guidance to cross-functional teams.

  • Must have strong leadership skills to