Regulatory Affairs Product Maximizer Director

Regulatory Affairs Product Maximizer Director

Lesuccès d'une entreprise passe avant tout par les hommes et femmes qui lacomposent...

Ensemble, partageons nos talents.

Ceva Santé Animale est la 1ère entreprise de santé animale française, etest classée au 5ème rang mondial.

Ensemble, c'est avec passion que les femmes et les hommes de Cevarecherchent, développent, produisent et commercialisent des solutions desanté innovantes pour soigner tous les animaux, et ainsi contribuer à lapréservation des grands équilibres de notre planète.

Nous nous engageons à assurer le meilleur niveau de soins et de bien-êtrepossible aux animaux d’élevage (volailles, porcs, ruminants), aux animaux decompagnie (chiens et chats) et à la faune sauvage.

En effet, notre vision « Ensemble, au-delà de la santé animale » met enavant le lien étroit qui existe entre la santé et le bien-être des personnes,des animaux et de notre planète. Ceva est plus que jamais engagé dans uneapproche « One Health », une seule santé en français.

Dans le cadre de notre politique "Diversité, équité et inclusion", Ceva Santé Animale s'engage en faveur de l'emploi des personnes en situation de handicap et déploie les moyens nécessaires au bon déroulement des entretiens de recrutement. N'hésitez pas à nous solliciter.

Location:

Lenexa, KS or Field

Lead the North American Product Maximization team and strategy for the biologics portfolio by ensuring product availability, lifecycle growth, regulatory compliance, and execution excellence across licensed products. Partner with Commercial, Manufacturing, Quality, Supply Chain, and Technical Services to identify and execute opportunities that maximize product value, expand market access, protect revenue streams, and ensure uninterrupted supply.

Build and lead a high-performing team responsible for licensed product lifecycle management, regulatory execution, portfolio optimization, and selected development support activities. Foster a culture of accountability, customer focus, innovation, and execution excellence while ensuring resources are aligned with the highest-value business opportunities.

Serve as the business owner and strategic leader for licensed products, providing direction on lifecycle management, label enhancements, manufacturing changes, market expansion opportunities, and regulatory strategies that support business growth. Additionally, contribute regulatory and commercial insight to development programs and new product opportunities to ensure future portfolio success.

Own the strategic direction and execution of regulatory activities supporting the North American licensed product portfolio. Establish product priorities and regulatory roadmaps that maximize product value, market access, and revenue growth. Lead cross-functional decision making regarding regulatory opportunities and risks. Ensure timely execution of regulatory commitments required to maintain product licenses and support business objectives. Assess business value, return on investment, and resource requirements associated with regulatory initiatives.

Monitor emerging regulatory changes and assess impacts on portfolio strategy. Build and maintain contact with the Authorities. Balance the risk vs quality. Be a member of trade associations. Share regular feedback to management teams. Build & maintain good relationships and provide foresight, co‑ordination of activities needed to influence regulatory decisions for the interest of Ceva through internal and external network (trade associations, regulatory authorities in country& region of origin of the campuses).

Allocate capacity and…