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:

Understand local regulatory requirements and responsible for all new product registrations, also including new claims and licenses variation & /or extension/renewal, to support business growth and business continuity, in compliance with local laws, regulations, guidelines and Elanco’s policies and SOPs.

Functions, Duties, Tasks:

• Coordination with supervisor, to develop effective strategies to cope with issues related to manufacturing site registration, product registration and maintenance of in line product post-market registration and renewals.
• Under the general direction of supervisor, independently perform product registrations including new product licensing and maintenance of existing product registrations and renewals.
• Compile registration dossier and prepare other regulatory documents (e.g., local package insert, packaging components) and ensure timely regulatory submission upon internal review and approval.
• Liaise and work effectively across the affiliate, regional and global teams e.g. product development, R& D, regulatory, CMC on fulfilling local regulatory requirements to support product applications and registration approvals for all products.
• Support potential manufacturing site change and/or Marketing Authorization transfer from legal regulatory owner to Elanco and maintain licenses in the markets through renewals and product variations for all Elanco products.
• Support the progress of the registration projects by coordinating with Elanco cross function in product registration process.
• To build close relationships with government agencies in order to expedite approval of product registration but not limited to regulatory inquiries, review committee meetings, sample testing and manage the government approval activities such as product registration to ensure smooth and timely introduction of new products according to business needs.
• Affiliate Responsible Person (ARP) for Pharmacovigilance for Taiwan – Ensure through collaboration with Global Pharmacovigilance where necessary, Affiliate compliance with Pharmacovigilance legislation and internal standards.
• Input and properly maintain all regulatory and legal documentation.
• Collect internal and external regulatory and competitive information and report to the supervisor.
• Establish and maintain general understanding and knowledge of regulatory requirements, regulatory affairs SOPs and other functional systems.
• Assist in Quality affairs projects and procedures that are related to regulatory affairs.
• Coordinate the execution of local development and/or post-marketing studies when applied.
• Other responsibilities and duties if assign needed.

Minimum Qualification (education, experience and/or training, required certifications):

• Bachelor degree of Medical Technology, and master degree of Pathology.
• At least 5-year experience in Veterinary Medicine / Pharmaceutical regulatory affairs, familiar with the local regulation.
• Strong communication skills in English (both written and spoken).
• Excellent interpersonal skills to handle sensitive and confidential information/situations and able to network effectively across groups and levels.
• Able to work and lead (a cross-function project) in a matrix environment.
• Able to work under pressure and compliance with strict deadlines.
• Multi-task oriented and with strong attention to detail.
• Advanced knowledge of MS Excel, Work, PowerPoint.

Additional Preferences:

• Influence: Builds relationships and influences internal and external customers, Team player.
• Accountability: Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case.
• Thinking capability: Analytical, Strategic, Creative, Good business judgment/knowledge
• Working Style: Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response/having sense of urgency, , Attention to details and adherence to guidelines.
• Values: Respect for People, Integrity and Excellence.
• Change mindset: Expected to play a key role in transformational change initiatives in the company (in merger & acquisition integration) but also need to be effective and practical in support of daily business work.
• Personal Brand: Resourceful, Assertive, Self-motivated, Energetic

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