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Principal Consultant - Global Regulatory New Product Development

Inseriert am: 20.08.2018

















































IdDemandeAuto / Automatischer Stellencode 43815
Titre d'emploi / Stellentitel Principal Consultant – Global Regulatory New Product Development
Ville / Stadt Basel
Régions / Staat Basel Stadt
Pays / Land Switzerland
Region Europe; Middle East; Africa
Emplacement de la position / Art der Stelle Local
Présentation de l'entreprise / Unternehmensüberblick

Founded in 1954, Elanco is a global research-based company that develops and delivers products and services to enhance animal health and production. Our products, services and global partnerships support our vision of enough food and companionship enriching life. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees in more than 70 countries.
Responsabilités / Verantwortlichkeiten Position Description:
Through the application of scientific training, regulatory acumen, and relevant experience, the Principal Consultant 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 Principal Consultant will: Take the lead role in developing the 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 Principal Consultant will also: Evaluate scientific information for potential molecule/product/ platform acquisition; participate and lead efforts within external organizations (e.g., IFAH, VICH, NOAH, AHI, AVMA, etc…) that support Elanco’s business objectives; act as an internal technical and regulatory resource for existing products in support of business affiliates and Market Access / 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

  • 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 New Product Value Analysis (NPVA), Research and Development Teams, and Global Marketing 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 regulatory strategy (e.g., submission / regulatory plan) and technical regulatory documents (e.g., 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 regulatory strategy

  • Participate in / contribute towards improvements in processes and procedures to deliver regulatory excellence in the new product development space

43815BR
Compétences requises / Qualifikationen Master's Degree or higher within the Sciences or equivalent experience.
Autres compétences / Zusätzliche Fähigkeiten/Präferenzen .
Informations complémentaires / Zusätzliche Informationen Location: Basel, Switzerland
Reports to: Advisor – CA Global Regulatory New Product Development
Travel requirements: 0-10%

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