Regulatory Affairs Specialist

Job description

     

JOB DESCRIPTION:

To prepare and submit regulatory applications to Food and Drug Administration.

Direct Reports: N/A

Sensitive/ confidential data handled: Product Dossier, Certificate of Product Registration (CPR), License to Operate (LTO), Manufacturing Agreement and Distributorship Agreement

Key Areas of Accountability:

·  To prepare and submit the following applications to Food and Drug Administration: 1. initial product registration; 2. renewal product registration; 3. product of variations; 4. safety label changes; 5. initial application for License to Operate; 6. renewal of License to Operate

·  to liaise with Food and Drug Administration and other government agencies to facilitate review and approval of applications in a timely manner

·  to liaise with Area Regulatory Team for regulatory submission requirements

·  to coordinate development of labeling material with Quality Assurance, Medical Affairs and Marketing

·  to review promotional materials and product publications on MIMS

·  to attend external seminars and educational sessions to monitor new regulatory updates and to communicate such changes to the organization

·  to ensure compliance of labeling materials with the Generics Law and other relevant laws

·  to ensure company’s compliance with Current Good Manufacturing Practice and other relevant regulatory guidelines

Job Specification

Knowledge & Experience:

Knowledge: Government Regulation and FDA requirements; Qualified Person in Industry Regulatory Affairs (QPIRA)

Experience: 2-3 years’ experience as RA Officer or Coordinator

Competencies required:

·  Computer Proficiency, Stakeholder Management and Organizational Skills
·  Provides high quality and reliable information in a timely fashion to direct and support business objectives and ensure compliance with health authority, hence performs the role of the qualified person in all the regulatory affairs issue.
·  Ensures all pharmaceutical materials (like packaging materials and promotional materials) comply with regulation of local health authorities

Minimum Qualification:

BS Pharmacy Graduate; Registered Pharmacist

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Philippines > Taguig City : Venice Corporate Center

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)