Regulatory Affairs Specialist (1 Year) - KL

Regulatory Affairs Specialist (1 Year) - KL

Salary : RM 3500 - RM 5500 + benefit + 1 month bonus

Overview : The Regulatory Project Specialist is mainly responsible for regulatory affairs support related to new and in-line products within the country. The activities encompass regulatory submissions to the authorities for marketing authorization transfer, new product registration, variations, and miscellaneous applications such as ad-hoc requests and permits, special exemptions when required, and general product maintenance. The Regulatory Project Specialist is expected to support expediting product commercialization by ensuring that local registration requirements are fulfilled and registration approvals are obtained in the shortest possible time.

Duties

• Regulatory Support : Support the Head of Regulatory Affairs (GRS-I) to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with company’s strategic objectives.
• Support submission of Marketing Authorization transfer and relevant post approval submissions.
• Support expediting product commercialization by ensuring that country’s registration requirements are fulfilled and registration approvals are obtained as quickly as possible.
• Review, analyse, coordinate and provide feedback to HRS (GRS-I) in matters relating to new product submissions and post approval maintenance of products as required.
• Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulatory plans across Pfizer’s portfolio.
• Support Labeling and Artwork change management activities for products in responsible portfolio to ensure compliance to information and implementation timelines.
• Review and approve consumer medicine information, packaging labels, promotional material and other documentation as required for regulatory compliance, when required (if applicable).
• Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications e.g. MIMS update.
• Support activities related to product licence maintenance and resolution of relevant regulatory issues.
• Support resolution of production and manufacturing issues, such as submission / negotiation strategy, sourcing issues, packaging issues, and compliance matters.
• Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
• Support the maintenance of the relevant record and Pfizer Systems while ensuring timely updates as governed by the SOP.
• Provides oversight and monthly report of activities associated with the approval of a product including such activities as development and coordination of responses to Regulatory Authority inquiries, monitoring and informing with respect to product filings, approvals and launches and track performance against agreed timelines and budget.
• Provide administrative and strategic support for Poison License and Clinical trial maintenance activities (where applicable).

Communication

Inventory Support

Marketing Support

Regulatory Compliance

Qualifications / Skills

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