Director, Global Regulatory Strategy Lead – Eye Health

🕒 il y a 14 jours

🌐 États-Unis, Allemagne – Distant

🇺🇸 États-Unis – Télétravail 🇩🇪 Allemagne – Télétravail

💵 $230 400 - $345 600 / an

⏰ Temps Plein

🟠 Senior

🧐 Stratégie

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 1%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Boehringer Ingelheim

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10 000+ employés

🏥 Santé

🏭 Fabrication

💊 Pharmaceutique

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim est une entreprise pharmaceutique mondiale, axée sur la recherche, et appartenant à une famille. Elle est basée en Allemagne et se consacre à la découverte, au développement, à la fabrication et à la commercialisation de médicaments sur ordonnance, de produits biopharmaceutiques, de vaccins et de produits de santé animale. L'entreprise se concentre sur des domaines thérapeutiques tels que les maladies respiratoires, cardiovasculaires, métaboliques, l'oncologie, l'immunologie et les maladies zoonotiques, et investit massivement dans la R&D et la biotechnologie pour faire progresser la découverte et le développement de médicaments. Elle opère dans le monde entier à la fois sur les marchés des produits pharmaceutiques humains et de la santé animale, en collaboration avec des institutions académiques et des entreprises biotechnologiques pour traduire la recherche scientifique en thérapies.

Description

• Provide strategic regulatory guidance and leadership throughout assigned products’ lifecycles • Develop and own global regulatory strategies for assigned assets • Lead the Regulatory Excellence Team and represent Global Regulatory Affairs on the Evidence Team • Assess regulatory risks, options, opportunities, and potential challenges • Propose innovative regulatory solutions to accelerate development and approval • Align regulatory strategies with business objectives, country prioritization, and regional requirements • Collaborate cross-functionally with Evidence, Asset, Regulatory Project Manager, and other stakeholders • Shape early target label profiles and provide input to the Company Core Datasheet • Support regional and local drug-labelling discussions • Oversee planning and execution of regulatory submissions • Support submission rollout for Rest of World countries • Oversee lifecycle-management strategies for marketed products, including variations, supplements, and line extensions • Monitor worldwide regulations, guidelines, trends, and regulatory intelligence • Communicate regulatory changes and recommend strategy adaptations • Develop contingency plans and provide risk/benefit analyses • Analyze competitive landscapes and identify innovative regulatory pathways • Contribute to health-authority meetings, briefing documents, policy development, and regulatory frameworks • Maintain oversight of local regulatory-affairs activities • Mentor team members and contribute to training, workshops, and knowledge-sharing • Provide regulatory input throughout product development and prepare teams for regulatory meetings, advisory committees, and inspections • Provide regular updates on regulatory milestones and project timelines

🎯 Exigences

• Bachelor’s degree in pharmacy, life sciences or chemistry required • Seven (7) years’ experience in regulated pharmaceutical industry (biologics or small molecule) required • In-depth knowledge of regulatory science and global regulatory requirements, guidelines, developments, and standards • Thorough understanding of regulatory processes and core drug development areas • Ability to analyze and interpret complex scientific data and regulatory guidelines • Ability to translate regulatory guidance into project-specific proposals and compliant regulatory solutions • Commercial awareness and understanding of business environment, therapeutic area, and development projects • Ability to work autonomously in a highly efficient manner • Critical thinking and ability to self-direct workload and meet tight timelines • Strategic mindset and top-down perspective • Adaptability, learning agility, and flexibility in changing regulatory environments • Proactive approach and ownership of regulatory challenges and opportunities • Effective leadership and team management skills • Strong interpersonal, relationship-building, and conflict-management skills • Excellent verbal and written communication skills • Ability to summarize complex scientific and regulatory questions into clear slides and text • Ability to prepare scenarios and decision trees • Strong organizational and time management skills • Fluency with MS Word, Excel, Project, and similar computer software • Must be legally authorized to work in the United States without restriction • Must be willing to take a drug test and post-offer physical if required • Must be 18 years of age or older • Master’s or doctoral degree, specialized pharmacist qualification, Master of Drug Regulatory Affairs, and RAC certification preferred or additional qualifications

🏖️ Avantages

• Competitive compensation and benefit programs • Medical coverage • Dental coverage • Vision coverage • Retirement savings opportunities • Paid time off • Paid holidays • Disability insurance • Life insurance benefits • Other company-sponsored programs • Role-specific discretionary bonus eligibility • Relocation compensation may be available • Work-life balance support • Mobility and networking opportunities • Professional development courses, conferences, workshops, and webinars

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