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:

Responsible for providing overall accountability for registration projects assigned & regulatory activities, in compliance with local applicable laws, regulations, guidelines, and Elanco’s policies and SOPs. Besides performing routine registration activities for new products, oversee and support potential manufacturing site change, Marketing Authorization transfer from legal regulatory owner to Elanco and maintain licenses in the markets through renewals and product variations for all Elanco products; the incumbent will assist in the development of regulatory affairs strategy and action plan as well as regulatory affairs activities assigned.

Functions, Duties, Tasks:

• Under the general direction of corporate strategy, independently perform product registrations including new product licensing and maintenance of existing product registrations and renewals.

• 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.

• Work effectively and flexibly within and across the affiliate, regional, and global team to achieve overall Elanco regulatory deliverables.

• 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.

• Provide technical expertise, local regulatory requirement understanding and sound scientific approach to global product development & R& D team.

• 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.

• Oversee and monitor the progress of the registration project.

• Network with regulatory agencies/institutes and continuous review and update of relevant government and industry regulations to the supervisor and/or relevant colleagues.

• Input and properly maintain all regulatory and legal documentation.

• Knowledge of key laws, regulations and policies affecting Elanco's business interests. Participates in meetings that drive affiliate’s strategy and outcomes.

• Assist in development and review regulatory affairs SOP and other functional system.

• Assist in Quality affairs projects and procedures that are relate to regulatory affair.

• Coordinate the execution of local development and/or post-marketing studies when applied.

• Local PV Responsible (LPVR) for Pharmacovigilance for Taiwan – Ensure through collaboration with Global Pharmacovigilance where necessary, Affiliate compliance with Pharmacovigilance legislation and internal standards.

• Final approver of the promotional material.

• Assist in any other regulatory tasks as assigned.

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

• At least with bachelor degree of veterinary medicine, animal science and pharmaceutical or chemical/biopharmaceutical/medical sciences.

• At least 6-year experience in Veterinary Medicine / Pharmaceutical regulatory affairs in global leading pharmaceutical company or well-known local company.

• Solid knowledge of the functioning of the local government systems including regulatory process and environments.

• 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.

• Good leadership and project management skills.

• Good team player.

• Demonstrates strategic thinking capability and ability to apply good judgment across diverse/complex issues.

• Ability to work under pressure and compliance with strict deadlines.

• Ability to priorities or work with conflicting priorities.

• Advanced knowledge of MS Excel, Word, PowerPoint.

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