Minimum RequirementsCandidate must possess at least a Bachelor's Degree, or Master's Degree of Pharmacy
A Registered Pharmacist with the Pharmacy Board of Malaysia
Possess good communication skills, strong leadership and interpersonal skills with an outgoing and pleasant personality
Positive working attitude, passionate about the Pharmacist profession in an Industrial setup
ESSENTIAL DUTIES AND RESPONSIBILITIES
Ensuring new and existing products meet with the registration requirements and to obtain or renew product licenses with the local pharmaceutical and medical device authorities as well as other foreign regulatory bodies prior to selling in Malaysia and other importing countries.
Maintain awareness of regulatory and pharmacovigilance requirements for pharmaceutical medical devices and other product categories for local and international markets.
To monitor relevant changes to local pharmacovigilance/regulatory regulations and advise the company of appropriate actions and solutions for compliance.
To advise on the legal and scientific restraints and requirements, collect, collate, evaluate scientific data and present registration documents to regulatory bodies and carry out the subsequent negotiations necessary to obtain and maintain registration approval for the products.
Conduct regulatory monitoring of company's approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of any amendment or change and takes appropriate regulatory actions. Responsible for archiving and maintaining all paper and electronic submission documents properly.
Ensuring specifications of products manufactured in the factory are consistent with the registration dossiers and annexes submitted to the local and foreign authorities.
To independently manage all regulatory and product life-cycle compliance activities of pharmaceutical, medical device and other product categories, including preparation and submission of new registration, license extensions, variations/change notifications, safety updates, renewals and ensure approvals in a timely manner.
Participating in the creation of regulatory strategies for new products and modifications to existing products aligned with business objectives.
Responsible for the registration or submission of documents with relevant authority, agencies, or corporate bodies for obtaining manufacturing rights, contract manufacturing, patents, trademarks, or any manufacturing collaborations and joint ventures.
Responsible to assist in reviewing and approval of artwork labeling according to local and foreign regulatory requirements and SOPs. To supervise the product label to comply with local and foreign regulatory authorities' requirements and coordinating with the supply chain to implement them in commercial shipments within the region.
Involved in the development of product marketing concepts and advertising before commercial launching and to provide regular reporting on registration and project status to management.
To supervise the activities of Pharmacovigilance and Post Market Surveillance Section including safety case intake and reporting, screening of local literature for safety information, participation in PV-relevant audits, management of risk minimization measures, preparation and coordination of Clinical Evaluation Report (CER) for medical devices including CE Marking.
Coordinate the information gathering for the preparation, amendment and updates for periodic safety update reports (PSUR) or Periodic Benefit Risk Evaluation Report(PBRER) and provide the information to local and/or foreign regulatory authorities if deemed necessary.#J-18808-Ljbffr