Job Description

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.

Position Description:

Assist RA Leader in providing overall accountability for registration projects assigned & regulatory activities in compliance with local applicable laws, regulations, guidelines, and Elanco\xe2\x80\x99s 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:

• Perform Regulatory Submission: product registration, renewal, and variation.
• Compile registration dossier and prepare other regulatory documents (e.g., local package inserts, packing components) and ensure timely regulatory submission upon internal review and approval.
• Coordinate with Elanco\xe2\x80\x99s internal departments (e.g. Vault RIM, BLUE, Vault Clinical) in product registration process.
• Communicate with regulatory agencies/institutes (e.g., NPRA, DVS, Pesticide Board, Plant Biosecurity Division) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
• AE/PC- timely/ closely monitor complains/ feedback from the field to ensure adverse events and product complaints reports submission as per Elanco SOP and global/ local regulatory requirements.
• Input and properly maintain all regulatory and legal documentation (Licenses, certificates etc.).
• Collaborate with cross-functions (Quality and Supply Chain and Regional Support Functions) to minimize supply disruption due to regulatory concern.
• Assist in Quality affairs projects and procedures that are related to regulatory affairs (Vault Quality).
• Review and approve promotional materials through regulatory affairs aspects (Vault PromoMats).
• Knowledge of key laws, regulations and policies affecting Elanco\xe2\x80\x99s regulatory interests.
• Participates in key government authorities\xe2\x80\x99 meetings that assist affiliate\xe2\x80\x99s strategy and outcomes.
• Support to influence and shape the government affairs environment to protect antibiotic franchise and organization\xe2\x80\x99s interest.
• Assist in establishment of affiliate strategies, policies and plans by providing advice from regulatory affair\xe2\x80\x99s insights. Involved in affiliate Market Access task force when required.
• Assist in any other regulatory tasks as assigned.
• Coordinate the execution of local development and/or post-marketing studies when applied.

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

• Bachelor\xe2\x80\x99s degree in veterinary medicine or pharmacy.
• At least 8-year experience in Veterinary Medicine/Pharmaceutical regulatory affairs in Malaysia - Solid knowledge of local functional skills.

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

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