Regional Regulatory Specialist

4 days ago

Petaling Jaya, Selangor, Malaysia Basf venezolana, s.a. Full time

About the Role:

We are seeking a highly skilled Regional Regulatory Manager to lead our regulatory strategy in Asia Pacific, ensuring compliance with regional and global regulations.

Key Responsibilities:

  • To define and implement regional regulatory strategies on assigned Professional & Specialty Solutions (P&SS) and Herbicide portfolio.
  • To provide strategic regulatory guidance to countries in Asia Pacific, securing and defending BASF's License to Operate on assigned portfolio.
  • To maintain close communication with global regulatory affairs regarding projects in Asia Pacific, preventing impacts to LTO in other regions.
  • To address regulatory issues and coordinate scientific support to country regulatory teams using internal/external expertise for new and existing registrations.
  • To steer specific activities related to registrations on assigned portfolio in the region, ensuring timely approvals and defense of products/active ingredients.
  • To advise regional business teams on regulatory issues and trends impacting business sales/strategy.

Main Areas of Responsibilities:

  • Provide strategic and high-impact regulatory guidance to Asia Pacific countries and Global Regulatory Affairs for securing and/or defending registrations of assigned portfolio within the region.
  • Define and optimize innovative regional and country registration strategies to support agreed business goals, expediting market launches and anticipating potential short- and long-term issues and trends.
  • Lead the implementation of regional registration plans and budget for assigned portfolio, approving and coordinating execution of related activities by scientific and registration teams involving marketing, global registration, functional units, technical development, compliance, and supply chain.
  • Lead communication and coordination between Global and Regional Regulatory Affairs to ensure alignment on portfolio regulatory decisions with broader impact beyond assigned portfolio LTO, and/or beyond Asia Pacific region.
  • Responsible for registration dossiers: drive content, review, and ensure consistency of parts provided by functional units; proactively and effectively communicate decisions to stakeholders. Drive related issues and scientific support. Interact and negotiate with high-level representatives from governmental authorities to achieve regulatory objectives and set appropriate requirements.
  • Maintain up-to-date regulatory project files and information, building a solid understanding of major regulations and related trends and their impact on the portfolio.
  • Support skill development of country regulatory managers in regulatory processes, regulatory project management, and driving regulatory changes.
  • Actively contribute to the development of stewardship and risk mitigation measures with Global and regional stakeholders to promote proper use of BASF products and compliance with regional and global standards.

Requirements:

  • Scientific background, equivalent of Bachelor's degree and preferably Master's in relevant scientific discipline (entomology, chemistry, toxicology, and agronomy).
  • Minimum 5 years' experience in regulatory affairs, preferably across two or more countries. Experience working with national regulatory authorities and/or in public health, pest control, and crop protection in Asia Pacific will be an advantage.
  • Strong science background.
  • Knowledge on regulatory procedures, requirements, and guidelines of agrochemicals/public health/pest control.
  • Strong command of English, written and spoken. Ability in another language will be an advantage.

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