Regulatory Affairs Associate
Regulatory Affairs Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Qualifications:
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Bachelor's Degree in Pharmacy
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Possesses good communication skills
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Preferable a Registered Pharmacist
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Has at least 23 years of Regulatory Affairs working experience
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Has direct experience of working with Regulatory Authorities
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Has knowledge of international guidelines and national legislation related to drug and medical device registration audits inspections and pharmacovigilance
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Experience with ASEAN regulations would be ideal
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Capable of developing and implementing regulatory strategies
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Competency in crossfunctional collaborations
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Willing to work on a hybrid setup
Job Descriptions:
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Obtaining drug products approvals in accordance with country regulations and Company policies and procedures in a timely manner in line with business needs through preparation and submission of the required documentation responding to deficiency letters and followup with local health authorities.
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Maintenance of approvals: Timely submissions and approvals of variations and renewals of already approved .
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Proactively identify regulatory requirements applicable to Sanitary Registers Renewals Variations and Pharmacovigilance as well as Laws Rules Codes Agreements Guidelines and internal requirements are well understood and communicated to the relevant stakeholders within the company especially potential impacts on company business.
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Adhere strictly the timelines in Corporate SOP for submitting the registration information to Regulatory Information Management System (RIMS) Data Entry Team and verifying RIMS data.
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Preparation of technical dossiers for hospital/Government tender applications.
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To support the internal and external GMP inspections defining strategies to respond to deficiency letters
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Defining strategies to respond to deficiency letters in issues related to importing advertising of drug products devieces and related substances as well as release of biologics and reduction of analysis.
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Review and approve promotional materials in accordance with local approved product information.
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Act as Local Safety Officer (LSO) for the Philippines subsidiary.
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Processing and reporting to Global Safety and Health Authorities all safety information received from market postauthorisation studies scientific literature and Health Authorities in accordance with national legislation and internal procedures.
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Manage the product quality complaint process and handle product recalls.
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Provide training to all employees and local agent(s) with regard to safety reporting complaint management and product recall.
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Provide QA oversight of activities performed by Marketing Authorization Holder (MAH)Ensures on time quality releasing for all products imported by the MAH to see if it passed the quality and regulation of Philippine market.
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Manage and report temperature deviation product complaint and labels deviation in Trackwise.
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Ensure no CAPA is pending or overdue.
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Accomplish SelfInspection report and CAPA Quality Audits and QRB reporting.
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Act as the Management Representative for Ferring Philippines to ensure that the processes needed for the local quality management system are established implemented and maintained.
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Ensures updates in Global SOP are reflected and implemented in the Local SOPs.
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Accomplish quarterly the Quality Performance Indicators (QPIs).
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Timely approval of Compliance request from Polaris.
Employment Type
Full Time
