1. Regulatory Planning
a) Regulatory Plan Development
Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan.
b) Process Management
i) Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation.
ii) Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.
2. Submissions and Approvals
a) Dossier Preparation
Prepare a quality regulatory dossier and submit within the planned affiliate timelines.
Activities include:
• Request and obtain the various regulatory items needed for the local submission
• Prepare/format the dossier to ensure it meets local requirements
• Implement the submission and archive appropriately
b) Gain Regulatory Approval
Gain MoH approvals to meet the affiliate product launch plans and ensure product maintenance.
Activities include:
• Provide quality responses to the Ministry of Health (MOH) by the due date
• Complete regulatory approval process and gain product licenses
• Communicate Product approval
• Archive submission dossier and approval documents
• Track post approval commitment, if any
• Perform regulatory responsibilities related packaging development
• Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs
c) Metrics Review
i) Prepare periodic Regulatory Report of actual submissions and approval
3. Regulatory Compliance
a) Compliance Maintenance
i) Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements [eg. all aspects of labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the DRA]
ii) Conduct periodic compliance self-audit to identify potential compliance issues
iii) Perform activities related to pharmacovigilance (PV) according to Corporate and if applicable, by local regulations.
iv) Take corrective actions plans based on regulatory audit findings
5. Additional Responsibilities
Responsible for preparation and submission of license pertaining to Legal Metrology, BIS, DPCO, E-waste, plastic waste and batteries waste registrations, for all technical documents, for the application of storage license for new wholesale license, if any.
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.