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DBV Technologies · 5 hours ago

Associate Director, Regulatory Affairs - Advertising & Promotion

Warren, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$130K/yr - $160K/yr

8+ years exp

DBV Technologies is a global clinical stage biopharmaceutical company focused on advancing epicutaneous immunotherapy for treating food allergies and other immunologic diseases. The Associate Director, Regulatory Affairs - Advertising & Promotion is responsible for ensuring that promotional materials meet regulatory requirements, collaborating with cross-functional teams, and providing regulatory review for promotional and medical content.

BiopharmaBiotechnologyHealth CareHealth Diagnostics

Responsibilities

Participate in review meetings providing regulatory input on promotional and non-promotional materials. Medical Materials may include medical slides, medical training materials, medical education materials, and others. Promotional/Marketing Materials may include advertising materials, speaker training materials, Commercial advisory board materials, peer-reviewed publications and others

Collaborate with material owners, reviewers and key internal partners to ensure alignment across assigned projects/materials. Key internal partners includes Medical, Legal, Compliance, Marketing, and Commercial

Represent Regulatory Affairs in Functional and Operational Meetings as it pertains to the Promotional or Medical Review Process and Best Practices

Prepare and review submissions seeking regulatory advice, support the resolution of FDA action letters, and lead company interactions with FDA Office of Prescription Drug Promotion (OPDP) and other health authorities

Ensure consistency with prescribing information and safety information

Ensure standardization of defined policies, SOPs, and best practices, and provide feedback and recommendations to optimize these processes and workflows

Coordinate and deliver ongoing company-wide regulatory training related to promotional requirements for company products

Participate in training programs for internal stakeholders including specifically Medical Affairs staff to ensure best practices, up to date knowledge, and operational excellence

Continuously monitor regulatory and compliance trends across the industry; analyze and interpret new regulations, guidance documents, and enforcement letters. Communicate updates on the evolving regulatory landscape, particularly within FDA’s OOPDP, to Regulatory Affairs, review committees, and other relevant stakeholders; develop or update procedures as needed

Support Regulatory Affairs with additional projects, as needed

Collaborate regularly with Legal, Compliance, and Medical Affairs; work with Quality on internal audits and CAPA activities as required

Qualification

Regulatory AffairsAdvertisingPromotionLeadership ExperienceUS Regulatory StandardsMicrosoft OfficeScientific KnowledgeCollaborationProblem-SolvingInterpersonal SkillsOrganizational SkillsIntegrity

Required

Bachelor's degree (required) in Life Sciences or a related discipline from an accredited four-year institution

>8 years of experience in pharmaceutical or biotech setting, including at least 5 years focused specifically on advertising and promotion

Working knowledge of US, EU, and Canadian health agency regulatory standards

Well-versed in scientific and clinical trial knowledge, documents, and vocabulary

Proficiency in Microsoft Office applications required

Demonstrated success in leadership, mentoring, and training experience within the advertising/promotion function of Regulatory Affairs is required

Strong understanding of complex medical and scientific concepts, including statistical data

Proven ability to build effective networks and influence outcomes without formal authority, including within cross-functional teams (Medical, Legal, Regulatory, etc.)

Creative problem-solving skills, with the ability to explore novel approaches to challenges and opportunities

Strong interpersonal skills with the ability to adapt communication style to gain alignment and acceptance of ideas or recommendations

Exceptional organizational skills with the ability to prioritize, manage multiple tasks simultaneously, and meet timelines independently

High level of integrity, with a commitment to accurate and transparent representation of information and data