Muntinlupa, Philippines
13 hours ago
Regulatory Affairs Specialist

In the Philippines, BASF has been supporting manufacturers from various industries since 1963. Today, BASF is a leading supplier of chemicals for industries, including Construction and Coatings, Automotive, Nutrition & Health, Home & Personal Care, and Agriculture. BASF also operates an Agricultural Research Station in the country which conducts research, laboratory studies and field testing of novel technologies. In 2022, BASF posted sales to customers in the Philippines of approximately €105 million and employed 97 people as of the end of the year. Further information is available at www.basf.com/ph.

 

Objectives of the position:

To lead new registrations and label expansions for Agriculture and address all regulatory compliance issues related to Crop Protection and Professional and Specialty Solutions (P&SS) Products with the Fertilizer and Pesticide Authority (FPA) and Food & Drug Administration (FDA). To ensure business continuity and growth with the timely renewal of necessary licenses and product registrations, and approval of new product registrations and label expansions.

 

Main areas of responsibility:

Ensure that Licenses-to-Operate (LTOs) and Certificates of Product Registrations (CPRs) are renewed and received on or before the date of validity to eliminate the disruption in sales and marketing activities; and are properly and securely archived.Perform regulatory assessment and submission of Experimental Use Permits (EUP) along with the preparation of Product Dossiers for new registrations as well as label expansions to support business growth by identifying future opportunities from existing products that can be registered in new crops or household use and reducing the existence of off-label usage by filing the necessary label expansions.Collaborate with accredited researchers and third-party laboratories for local field trials and analytical tests that are required; coordinate data requirements such as bio-efficacy, residue studies, ecotoxicity, consumer safety and other requirements as well as handling of all samples for confirmatory analysis needed to secure the approval of new and label expansion projects in the agreed realistic timeline. Spearhead review of field trial protocols and terminal reports prepared by researchers for EUP or Full Registration application. Monitor execution up to completion of local field trials such as Bio-efficacy and Supervised Pesticide Residue Trial (SPRT).Support the Regulatory Affairs Manager in registration amendments (e.g., change in recipe, Active Ingredients, sources, packaging, and other modifications) and in addressing potential label compliance issues in all Agriculture products by proactively identifying and resolving possible compliance issues together with the local sales team, and regional and global regulatory teams.Responsible in the creation of packaging label for artwork development in coordination with local marketing, sales, product development, supply chain and regional regulatory team to ensure recommended registration data/Good Agricultural Practices (GAP) and product stewardship are communicated properly to the end users.Monitor the progress and status of all applications and demonstrate proactive interaction with the local regulatory agency for timely CPR and LTO approvals. Develop and maintain strong relationship with relevant external authorities, non-government organizations and relevant BASF colleagues in the country.Assist the Regulatory Affairs Manager in providing expert advice and assistance to the Agro-Research Station on their EUP submissions, and license-renewal of the Shipment Hub by liaising with regulatory agencies.Provide regular market intelligence on new product registrations, label expansions and off patents of key competitors.Act as an alternative representative of BASF in external meetings/forums especially in Crop Life Philippines (CLP), specifically in the Technical & Regulatory (T&R) and Environmental Science (ES) Committee when needed.Maintain up-to-date regulatory information in systems/database and ensure proper documentation and records management.Handle administrative tasks related to research contracts, quotations, and payment processing. Support the Regulatory Affairs Manager in all/any product registration tasks/topics as identified and whenever needed.

 

Minimum qualifications:

Bachelor's Degree in science-based courses such as Agriculture with Major in Entomology, Pathology, Agronomy or Weed Science, Chemical Engineering, Chemistry, Pharmacy. Biology or Biotechnology; preferably licensed.At least 3-5 years of combined experience in country registration management, crop biology trials set-up (e.g., design, analysis), agronomy, horticultural field experience, pesticide regulatory affairs or pest control operations.Knowledgeable of science-based principles and practices, registration requirements and guidelines, agricultural experiment/trial set-up and statistical analysis, sample management, and chemical handling and safety precautions.Possess strong strategic planning, project management and influencing skills.Knowledgeable of MS Office applications including MS Project software.With very good relationship building, interpersonal communication and personal presentation.Demonstrate leadership, professionalism, and integrity at work.Demonstrate high level of energy and maintain stable performance under pressure.Proactive, can work independently and in teams.Possess a valid driver’s license.
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