Title:  Regulatory Affairs Assistant - Performance Materials

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.

1. Acts as the authorized representative in charge to perform duties and responsibilities and to establish good relationship with governing agencies.

2. Prepares, reviews and submits regulatory filings including applications, amendments, renewals and updates to relevant authorities.
3. Develop, review and maintain accurate and detailed records of all submissions, communications and approvals.
4. Ensures ongoing compliance with applicable regulatory requirements.
5. Conducts periodic audits and inspections to assess compliance and prepare reports for leadership team.
6. Monitors regulatory changes and update internal customers about new regulations, guidance documents and policies.
7. 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.
8. Identify regulatory risks and develop a mitigation to address regulatory challenges.
9. 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

1. 1.            Good networking, inter-cultural thinking and understanding
   2.            Good communication skills
   3. Strong attention to detail and analytical skill
   4. Ability to manage multiple projects and prioritize tasks effectively

Education

Bachelor of Science in Pharmacy / Food Technology / Chemical Engineering / Chemistry