Regulatory Affairs Executive

at  Elanco

POSITION DESCRIPTION:

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.

MINIMUM QUALIFICATION (EDUCATION, EXPERIENCE AND/OR TRAINING, REQUIRED CERTIFICATIONS):

• Bachelor’s degree in veterinary medicine or pharmacy.
• At least 3-years’ experience in Veterinary Medicine/Pharmaceutical regulatory affairs in Malaysia - Solid knowledge of local functional skills.

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’s internal departments (e.g. Vault RIM, BLUE, Vault Clinical) in product registration process.
• Communicate with regulatory agencies/institutes (e.g., NPRA, DVS, Pesticide Board) 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.
• Participate in association meetings that assist affiliate’s strategy and outcomes.
• Review and approve promotional materials through regulatory affairs aspects (Vault PromoMats).
• Knowledge of key laws, regulations and policies affecting Elanco’s regulatory interests.
• Assist in any other regulatory tasks as assigned.
• Compliance with company rules and regulations including Ethics & Compliance and external laws and regulations.