Regulatory Affairs Officer

Industry Category	Sciences	Position	Chemistry
Recruitment Department		Number Of Recruits	several
Work Location	Metro Manila (NCR) Muntinlupa	Nature Of Work	Full Time
Gender Requirements	Male	Marriage Requirement	No marital status restrictions
Education Level	Open to all levels	Work Experience	No work experience restrictions
Age Requirement	Above 18 years old	Salary Package	Negotiable
Updated Date	2022-10-04	Valid Until	Long-term validity

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:

Manage Regulatory Operations and Compliance ServicesEstablish rapport with government authorities and drive timely approval of applications to ensure unhampered business operation and continuous business developmentsPlan 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 timelineDevelop and implement documented regulatory end-to-end process to establish efficient and systematic work structure.Champion Product StewardshipImplement 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 complianceAssist 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 informationData Gate KeeperEstablish, 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 stakeholdersEnsure 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.

At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. More than 110,000 employees in the BASF Group contribute to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into six segments: Chemicals, Materials, Industrial Solutions, Surface Technologies, Nutrition & Care and Agricultural Solutions. BASF generated sales of €59 billion in 2020. BASF shares are traded on the stock exchange in Frankfurt (BAS) and as American Depositary Receipts (BASFY) in the U.S. Further information atwww.basf.com. 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 2020, BASF posted sales to customers in the Philippines of approximately €76 million and employed 84 people as of the end of the year. Further information is available on the internet atwww.basf.com/ph.