16 days old

Regulatory Affairs Specialist

Elanco
Petaling Jaya, Selangor 46150
  • Job Code
    R0009385

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.


Position Description:

To assist RA Manager in providing overall accountability for registration projects assigned & regulatory activities in compliance with local applicable laws, regulations, guidelines, and Elancos 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 supervisor, assist in performing product registration.
  • Assist in compiling registration dossier and prepare other regulatory documents (e.g., local package inserts, packing components) and ensure timely regulatory submission upon internal review and approval.
  • Assist in for the progress of the registration project. Coordinate with Elancos internal departments (using Vault RIM, BLUE etc. systems) in product registration process.
  • Assist in communicate with regulatory agencies/institutes (e.g., Pesticide Board, Plant Biosecurity Division, NPRA, DVS etc.) on the product registration, including but not limited to regulatory inquires, review committee meeting, sample testing.
  • Pharmacovigilance Reporting- timely/closely monitor complaints/feedback from the field to ensure adverse events and product complaints reports submission as per Elanco SOP and global/local regulatory requirements.
  • Assist in input and properly maintain all regulatory and legal documentation.
  • Knowledge of key laws, regulations and policies affecting Elancos regulatory interests. Participates in some meetings that assist affiliates strategy and outcomes.
  • Assist in Quality affairs project and procedures that are related to regulatory affairs.
  • Assist in any other applicable regulatory tasks as assigned.
  • Review and approve promotional materials through regulatory affairs aspects.
  • Compliance with company rules and regulations including Ethics & Compliance and external laws and regulations.

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

  • Bachelors degree of animal science or chemical/ biopharmaceutical sciences.
  • 3 to 5 years experience as Regulatory Affairs in Bio-protection (Pesticides Registration)

Additional Preferences:

  • Good communication skills in English (both written and spoken).
  • Good interpersonal skills to handle sensitive and confidential information/ situation and able to network effectively across groups and levels.
  • Good team player.
  • Demonstrates strategic thinking capability and ability to apply good judgement 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







Posted: 2022-01-07 Expires: 2022-02-05
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Regulatory Affairs Specialist

Elanco
Petaling Jaya, Selangor 46150

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