Regulatory Affairs SpecialistAbbott

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)
Abbott

Taguig City, Metro Manila
Permanent
Full-time