Regulatory Affairs Specialist
2 semanas atrás
Elanco is a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success. Our team values and champions new ways of thinking, working with dynamic individuals, and acquiring new skills and experiences that propel careers to new heights.
This role offers a competitive salary range of $120,000 - $180,000 per year, depending on experience and qualifications. The estimated salary for this position is $150,000 per year, considering the industry standards and location.
Job DescriptionThe Regulatory Advisor will have a deep understanding of the overall pharmaceutical development process and be able to foster a molecule from a product concept through the development process to approval and data-driven life cycle management (LCM) evolution for Safety and Efficacy (S&E).
Key responsibilities include:
- Taking the lead role in developing the global regulatory strategy for a product concept;
- Critically evaluating both early and late phase data in support of product development;
- Effectively working within a cross-functional team responsible for the creation, establishment, and delivery of an effective development program;
- Developing and being responsible for the regulatory strategy in support of global product registration, commercialization, and LCM (S&E);
- Leading discussions with external partners and/or customers to further refine regulatory strategies;
- Driving submission execution to maintain compliance, meet the reporting requirements for the registration and approval of new animal drug/veterinary medicinal/specified feed additive applications, within optimal timelines and achieving business-appropriate labels.
This role requires a strong understanding of the animal health industry and the animal drug development process, as well as experience in regulatory affairs. A Master's degree or higher within the sciences, degree in veterinary medicine, or equivalent experience is required.
A competitive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off, is also offered.
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