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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 Roches sales marketing and other commercial teams to develop and implement the effective sale distribution marketing and advertising of Roches 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 Roches 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 teams 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 inspire empower and develop regulatory professionals with a desire to coach and develop the team.

  • Previous experience managing direct reports stakeholders and/or cross-functional teams to successfully complete objectives/projects.

  • Excellent communication and interpersonal skills with ability to effectively collaborate with internal and external stakeholders.

  • Willingness and ability to deliver a consistent message in the face of pressure or adversity.

  • Ability to encourage transparent and connected culture between the Legal and Compliance Department and business stakeholders.

This position is based in Indianapolis IN and has an in office requirement of 3 days/wk.

The expected salary range for this position based on the primary location of Indiana is $188200 - 349400. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.