Senior Regulatory Consultant – Advertising & Promotion

🕒 il y a 15 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Recevoir des emails pour des emplois à distance

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Parexel

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1983

⚕️ Assurance santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 Venture Round en 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel est l'une des plus grandes organisations de recherche clinique (CRO) au monde, fournissant des services complets pour le processus de développement clinique de la Phase I à IV. L'entreprise se spécialise dans la gestion de portefeuille, la gestion des essais cliniques, la stratégie réglementaire, l'accès au marché et la gestion du cycle de vie des produits biopharmaceutiques. Parexel vise à accélérer la mise sur le marché de médicaments qui changent la vie en tirant parti de son expertise clinique, réglementaire et thérapeutique. Avec une équipe mondiale de plus de 21 000 professionnels, Parexel s'efforce d'intégrer les perspectives des patients et des conceptions d'essais innovantes pour développer des traitements dans des domaines thérapeutiques tels que l'oncologie, les neurosciences, les maladies rares et plus encore. Elle se concentre sur la fourniture d'essais cliniques centrés sur le patient et efficaces.

Description

• Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams • Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios • Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements) • Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy • Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs • Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy • Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications • Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations • Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes • Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders • Mentor junior team members and contribute to building organizational regulatory capability

🎯 Exigences

• 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion • Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities • Proven ability to act as a strategic advisor and trusted partner to senior stakeholders • Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams • Demonstrated ability to independently review promotional materials and make sound regulatory decisions • Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly • Excellent communication, influence, and stakeholder management skills • Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

🏖️ Avantages

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development