Regulatory Affairs Officer

2 weeks ago

Manila, National Capital Region, Philippines BASF Philippines Inc. Full time

Objective of the position:

To deliver Product Safety Service tasks to safeguard compliance to Philippine legislations and company directives to ensure business continuity and operations of businesses under care of Philippine Product Safety. Main Areas of Responsibilities:Establish rapport with government authorities and drive timely approval of applications to ensure unhampered business operation and continuous business developments.Plan and align registration strategy with stakeholders by providing wholistic view of the requirement including data gap assessment and advise alternative approach to be able to agree on realistic timeline.Develop and implement documented regulatory end-to-end process to establish efficient and systematic work structure.Implement applicable regulatory conditions such as but not limited to country label requirement; post notification requirements, post registration requirements and reporting requirements through engagement with internal stakeholders and functional supports to achieve full regulatory compliance.Assist in regulatory monitoring focusing on area of specialization. Work with Product Safety Country Expert and relevant Operational Divisions in analysis and impact assessment for a provision of Management of Change.Drive regulatory advocacy with alignment to corporate BASF positions as appropriate in the local context through engagement with local industry associations and participation in relevant activities capacity building, workshops, etc.Provide periodic training and professional advice to stakeholders under area of specialization to ensure dissemination of updated information.Establish, manage, and maintain central documentation of submissions and relevant correspondence with authorities ensuring implementation of proper controls in CBI handling.Ensure appropriate and updated maintenance of country monitoring database and /or Operational Division Registration Database to provide visible status to stakeholders.Ensure initiation of BASF Reference & Real Substances Data maintenance according to NSN to warrant appropriate country regulatory status in BASIS. Minimum Qualifications:Bachelor's Degree in Pharmacy with valid professional license. FDA Qualified Person in Industry Regulatory Affairs accreditation is an advantage.With 3-5 years of work experience in chemical or allied industry dealing with quality management or regulatory affairs. Experience in multi-national companies or large local companies with matrix organizational setup is preferred.Knowledgeable of organic and inorganic chemistry, polymer chemistry; analytical chemistry and quantitative analysis.Possess basic to in-depth knowledge of Philippine Chemical Legislations.With good analytical and problem-solving skills.Possess good organizational skills, a proactive mindset, and ability to multitask and prioritize work.Express self well in English both orally and in writing.Proficient in Windows and MS Office Applications.Demonstrate leadership, professionalism, and integrity at work.Proactive, can work independently and in teams. All applications will be treated confidentially. Only short-listed candidates will be interviewed.

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