At Elanco (NYSE : ELAN) it all starts with animals!
As a global leader in animal health, we are 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.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success.
Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better join our team today!
Position Description: Through the application of scientific training, regulatory acumen, and relevant experience, the 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).
- Specifically, the Regulatory Advisor will:
Take the lead role in developing the global regulatory strategy for a product concept;
Critically evaluate both early and late phase data in support of product development;
Effectively work within a cross-functional team responsible for the creation, establishment, and delivery of an effective development program;
Develop and be responsible for the regulatory strategy in support of global product registration, commercialization, and LCM (S&E);
Lead discussions with external partners and/or customers to further refine regulatory strategies;
Drive 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.
Provide regulatory and technical overview of submissions (dossiers/non-CMC technical sections) pertaining to a product's approval.
- The Regulatory Advisor will also:
Evaluate scientific information for potential molecule/product/platform acquisition;
Participate and lead efforts within external organizations (VICH, NOAH, AHI, AVMA, Animal Health Europe, etc.) that support Elanco's business objectives;
Act as an internal technical and regulatory resource for existing products in support of business affiliates and government affairs as well as globalization of these existing products.
Functions, Duties, Tasks: Comprehension of and contribution to scientific components (existing data and literature) and how it relates to regulatory strategy globally.
Understand and evaluate a proposed product concept to provide the best possible product for the customer and increase Probability of Technical Success (PTS).
Collaborate with Marketing, Research and Development Teams and any other relevant teams to develop and maintain draft launch labels (DLL).
Prepare and maintain text based Mock labels to inform commercial labelling throughout the development process.
Design and develop creative global regulatory strategy (submission/regulatory plan) and technical regulatory documents (data H-Submissions, Innovation Task Force (ITF), Scientific Advice etc.) based on interpretation of both regulatory and scientific information.
Lead compliant commercial label delivery during pre-launch phase across major geographies (EU/US).
Knowledge of and compliance with relevant laws and regulations, and global policies and procedures.
Maintain a positive business collaboration and partnership with regulatory authorities.
Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review.
Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers.
Lead submission preparation to provide high quality submissions, reducing questions/hearings, leading to optimal review times and speed to market.
Maintain a level of competency of current scientific information through review of scientific literature as well as communications with industry key opinion leaders (KOLs).
Collaborate with development teams in the design, conduct and reporting of studies (both early and late stage development).
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Collaborate on and review scientific documents including protocols and final reports to assure consistency with DLL and global regulatory strategy.
Participate in/contribute towards improvements in processes and procedures to deliver regulatory excellence in the new product development space.
Participate in post approval strategy and delivery globally.
- Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training.
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Minimum Qualification: Education:
Masters degree or higher within the sciences, degree in veterinary medicine or equivalent experience.
Experience:
Regulatory Affairs experience.
Understanding of the animal health industry and the animal drug development process.
Additional Preferences: Languages: Fluency in English (verbal and written).
Other Information: Expected Travel: Up to 20 - 25%.
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