Regulatory Affairs Assistant Performance Materials
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Job Location:
Taguig - Philippines
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Regulatory Affairs Specialist
To handle FBI and PHI Finished Product
General Responsibilities
Manages regulatory processes and ensures products such as but limited to pharmaceuticals animal health care medical devices food cosmetics household urban hazardous substances and chemicals comply with relevant laws regulations and standards set by regulatory agencies.
Responsible in updating the inventory of applicable regulations which involves organizing reviewing and ensuring accuracy in the list of applicable rules guidelines or laws for a particular product.
- Acts as the authorized representative in charge to perform duties and responsibilities and to establish good relationship with governing agencies.
- Prepares reviews and submits regulatory filings including applications amendments renewals and updates to relevant authorities.
- Develop review and maintain accurate and detailed records of all submissions communications and approvals.
- Ensures ongoing compliance with applicable regulatory requirements.
- Conducts periodic audits and inspections to assess compliance and prepare reports for leadership team.
- Monitors regulatory changes and update internal customers about new regulations guidance documents and policies.
- Collaborates with research and development quality assurance custom compliance customer service and sales to ensure regulatory requirements are incorporated into product development and business processes.
- Identify regulatory risks and develop a mitigation to address regulatory challenges.
- Support long term planning by advising on regulatory considerations and participate in developing regulatory strategies for product approvals.
Functional Skills and Knowledge
a. Bachelor of Science in Pharmacy / Food Technology / Chemical Engineering / Chemistry
b. Licensed Pharmacist is an advantage with minimum of 1-year experience as regulatory.
c. Good working knowledge comprehension and application of local regulations
d. Ability to work with changing priorities.
e. A detail-oriented individual who can work independently and exercise sound judgment in the application of registration requirements.
Skills
- Good networking inter-cultural thinking and understanding
- Good communication skills
- Strong attention to detail and analytical skill
- Ability to manage multiple projects and prioritize tasks effectively
Education
Bachelor of Science in Pharmacy / Food Technology / Chemical Engineering / Chemistry
Required Experience:
Junior IC
Key Skills
- Computer
- Anti Money Laundering
- ASP.NET
- Advisory
- IT Support
- Maintenance Engineering
About Company
DKSH Spain distributes, markets, and sells high-quality products and brands, helping businesses in Spain develop and grow.
