Apply on Employer Site

Madrigal Pharmaceuticals · 5 months ago

Associate Director, Regulatory Affairs, Advertising and Promotion

Waltham, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$170K/yr - $208K/yr

7+ years exp

Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to support the business's promotional needs in a compliant manner, including reviewing regulatory content and managing interactions with regulatory bodies.

BiopharmaBiotechnologyMedical DevicePharmaceutical

Responsibilities

Reviewing and approving the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices

Represent the commercial regulatory perspective at the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance

Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials

Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of Madrigal products

Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities

Manage interaction with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253

Ensuring stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels in a timely manner

Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts

Provide training on FDA regulations for advertising and promotion to employees and agents of Madrigal

Participate in company working groups on advertising and promotion standards and guidelines

Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims

Qualification

Regulatory strategyFDA regulationsPromotional review softwarePharmaceutical industry experienceCommunication skillsTraining abilityAttention to detailNegotiation skillsTeam collaboration

Required

BA/BS degree in a scientific discipline

Minimum 7+ years of Pharmaceutical/Biotech industry experience in drug advertising and promotion review

4+ years' experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations, and guidance documents

Direct experience communicating with OPDP

Excellent verbal, written communication skills

Strong attention to detail with the ability to check documents for accuracy as well as consistency

Proficiency using promotional review software, such as Veeva Promomats

Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives

Knowledge of clinical study design and statistical analyses in the assessment of promotional claims

Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders

Consistently meets deadlines without compromise to work

Ability to distill complexity into understandable and actionable language

Willingness to travel to various meetings or sites, including overnight trips