Regulatory Affairs Officer

GENERAL FUNCTION

This position is responsible for:

1.Leads regulatory recommendation and compliance to the regulations of FDA, Halal and other regulatory body agencies.

1. Leads in the management of the Quality Control laboratory (testing, documentation, compliance to SOPs/WIs, achievement of KPIs, and overall upkeep and maintenance)
2. Setting up and implementing standards and procedures for the following QA functions: complaints, recalls, change control, management of CAPA, external audits (suppliers and tollers), product quality review, and quality control.

DUTIES AND RESPONSIBILITIES

REGULATORY AFFAIRS

1.Ensures that Lamoiyan is up to date on the various regulations relevant to its operations. Prepares and discusses action plans so that the new regulations will have minimal impact or disruption to the Lamoiyan business.

2.Ensures that Lamoiyan and its affiliate companies have the required licenses

3.Ensures timely application and renewal of product notifications and marketing authorizations.

4.Ensures that licenses of toll manufacturer are updated and keeps copies of these on file.

5.Prepares and maintains Product Information File (PIFs) for all cosmetic products as required by ASEAN Cosmetic Directive.

6.Monitors validity of promo permits and coordinates with Sales, Marketing and Trade Marketing Groups if there is a need to extend validity dates.

7.Maintains Halal accreditation of Lamoiyan and certification of its products.

8.Handles all activities related to intellectual property protection.

9.Represents the company during key external stakeholders and regulatory partner's audits.

QUALITY ASSURANCE

1.Evaluates adequacy of quality assurance standards and formulates strategies and plans to address gaps or issues.

2.Identifies training needs to ensure quality awareness and compliance within the organization and organizes training interventions.

3.Facilitates investigation of complaints and ensures that appropriate corrective and preventive actions are implemented to address these.

4.Leads and manages the company's change control process and product complaints.

5.Implements a risk management program and monitors completion of risk mitigation actions.

6.Assures consistent compliance of the company with quality, regulatory and ISO requirements.

7.Leads and conducts external audits of suppliers and toll manufacturers

8.Facilitates conduct of product quality reviews.

9.Ensure that an effective CAPA system is in place to address internal and supplier/toller quality issues.

10.Stands in as alternate responsible person (in the absence of Operational Quality Assistant Manager)

for batch release.

QUALITY CONTROL

1.Ensure that the laboratory is functioning effectively and efficiently to serve the requirements of it's internal and external customers.

1. Helps facilitate laboratory investigation of out-of-specification results and documentation of outcome of investigation and identified corrective and preventive actions.
2. Developing quality control policies and standards.
3. Oversee QC tasks, ensuring proper documentation of records and review of reports (e.g., Certificate of Analysis) submitted to regulatory authorities and customers.
4. Assists in ensuring that Good Laboratory Practice (GLP) is observed in the laboratory at all times.
5. Helps put in place a safety program in the laboratory and ensuring compliance to safety standards.

COMPETENCY REQUIREMENTS

Technical Competency: Knowledge on Regulatory standards and requirements; Knowledge of Audit and CAPA processes

Communication Skills: Able to express ideas in a clear and concise manner

Interpersonal Skills: Able to collaborate and interact effectively with different types of people and in all levels in the organization

Analytical and Problem Solving Skills: Able to analyze and apply rationale thinking in solving problematic situations

Resiliency: Able to control and filter emotions in a constructive manner

Leadership: Able to take initiative and work with minimum supervision

JOB QUALIFICATIONS AND EXPERIENCE LEVEL

Graduate of Pharmacy or Industrial Pharmacy, Licensed

Membership in an industry related professional body would be advantageous

Significant experience in a manufacturing environment

Relevant work experience in Regulatory, Audit, Quality Systems and Quality Assurance

Organized, efficient, self-starter, results oriented and keen to details