As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Advisor, Regulatory Affairs – Biologicals for Elanco Animal Health is responsible for providing regulatory guidance resulting in comprehensive, cohesive, and compliant submissions and interactions in order to obtain and maintain product licenses and product availability. The individual in this role interacts with the USDA Center for Veterinary Biologics (CVB) and internal stakeholders to drive regulatory solutions.
The incumbent would be responsible for having a thorough understanding of the regulations in order to work independently within a cross-functional team. Additionally, the individual in this role will focus on interacting positively while developing relationships with internal and external stakeholders including R&D manufacturing, quality, and third party and trade association groups. The individual in this role is expected to perform key leadership responsibilities which provide innovative solutions, a positive and motivating work environment, ultimately delivering the Elanco pipeline and maintaining established product licenses.
Functions, Duties, Task:
Key Technical Responsibilities:.
- Responsible for having a thorough understanding of the regulations in order to work independently within a cross-functional team.
- Anticipates and resolves complex problems to maintain product to market.
- Subject matter expertise to advise R&D,QC, QA, and Manufacturing on regulatory aspects.
- Ensure inspection readiness from regulatory perspective. Includes oversight of RA review of manufacturing direction templates for alignment with regulatory documents.
- Build tools, systems, and business process to develop best in capabilities.
- Reviews submissions to ensure they are scientifically sound, accurate, and compliant
- Coordinate, supervise and review commitment responses.
- Actively participates in meetings that drive strategy and outcomes. Includes strategies from innovation through product post-approval.
Key Leadership Responsibilities:
- Proactively search for opportunities for continuous improvement and facilitate implementation of new standards and practices with the ability to think “out of the box”.
- Provide and accept challenge to deliver regulatory solutions and opportunities while creating an innovative culture.
- Work effectively and flexibly within and across all Elanco teams, external collaborators, government agencies, and affiliates to assist in achieving overall Elanco deliverables.
- Create a positive, engaging, and inspiring work environment that is aligned with company objectives.
- Influence others to adopt a different view to create an innovative culture.
- Create an engaging culture with a “Play to Win” mentality, and identifying essential wins.
- Excellent interpersonal and communication skills.
- Bachelor’s Degree in Biology, Microbiology or Immunology or related area
- Minimum 10 years in a veterinary vaccine manufacturing setting
- Experience in working with USDA CVB
- Qualified candidates need to be authorized to work in the United States. Elanco does not anticipate visa (e.g. H1B) sponsorship for this position.
- Strong understanding of varied regulatory requirements related to veterinary vaccine manufacturing.
- Previous experience in R&D and/or Quality
- Knowledge of Continuous Improvement Six Sigma and Lean Principles
- Experience of working with novel regulatory pathways/mechanisms would be advantageous.
- Expected Travel : 10-25%
- This is a director level position without direct reports
- This role can be done remotel
Notification of Drug testing and Background Checks
Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status