Regulatory Affairs Specialist

Job description

We are a leading chemical company, with the best teams developing intelligent solutions for our customers and for a sustainable future. Our success as a company relies on the engagement of our employees. We encourage our employees to develop their strengths, and we recognize their achievements. For you, this means a wide variety of job roles, and exciting opportunities for learning and career development.

Description

Description:

In the Philippines, BASF has been enabling manufacturers in various industries since 1963. Today, BASF Philippines, Inc. is a leading supplier of chemicals for industries including construction and coatings, automotive, health and nutrition, personal and home care, chemicals and plastics, and agriculture. BASF also operates an agricultural research station which conducts research, laboratory studies and field testing of novel technologies as part of BASF’s global research effort in the field of agricultural solutions. In 2018, BASF posted sales to customers in Philippines of approximately €113 million and employed 95 people as of the end of the year. Further information on BASF in the Philippines is available at www.basf.com/ph.

 

Objective of the position:

·  To create a sustainable and long-term product stewardship program for crop protection and address regulatory compliance issues by ensuring availability of valid licenses and product registrations

 

Main Areas of Responsibilities:

·  Ensure that all 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.
·  Lead submission of label expansions/extensions to support business growth by identifying future opportunities from existing products that can be registered in new crops or uses; reducing the existence of off-label usage by filing the necessary label expansions; managing bio-efficacy trials that are required during label expansions; and securing the approval of label expansion projects in the agreed realistic timeline.
·  Create and ensure implementation of a long-term and sustainable stewardship program across all crop protection products by supporting regional and global product stewardship initiatives, and engaging regulatory agencies (Fertilizers and Pesticide Authority and Food and Drug Administration) in the dissemination of product stewardship programs.
·  Support the Regulatory Supervisor in addressing potential label compliance issues in all crop protection products by proactively identifying and resolving possible compliance issues together with the local sales team, and regional and global regulatory teams. Provides regular market intelligence on new product registrations, label expansions and off patents of key competitors.
·  Support the Regulatory Supervisor in providing expert advice and assistance to the Agro-Research Station on their Experimental User Permit (EUP) submissions, and license-renewal of the Shipment Hub by liaising with regulatory agencies (i.e., FPA, FDA, BAFS and BPI).
·  Act as an alternate company representative to external meetings/fora particularly in the Technical & Regulatory (T&R), and Environmental Science Committees of Crop Life Philippines (CLP).
·  Maintains updated regulatory information in business unit databases.

 

Minimum Education and Qualification Required:

·  Bachelor's Degree in Biology, Chemistry, and Agriculture with Major in Entomology, Plant Pathology, Agronomy-Weed Science, Pharmacy or Biotechnology.
·  With at least 1-2 years combined experience in country registration management/crop biology trials set-up (design, analysis), agronomy, horticultural field experience or pesticide regulatory affairs. Experience is the pharmaceutical industry will also be considered.
·  Knowledgeable of science based-principles and practices, registration requirements and guidelines, agricultural experiment/trial set-up and statistical analysis and sample management.
·  With strong planning, project management and influencing skills.
·  Possess very good communication skills, written and verbal.
·  Have good organizational skills, a proactive mindset, and ability to multitask and prioritize work.
·  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.