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Regulatory Assistant

2022-09-26 04:40菲律宾2910
区域:Metro Manila (NCR)Quezon City
行业:Healthcare
职位:Pharmacy
部门:
人数:若干
性质:Full Time
性别:Male
婚姻:No marital status restrictions
学历: College Diploma
经验:不限
年龄:18岁以上
待遇:面议

JOB OUTPUTS

· Complies and provide documents required by Food and Drug Administration and Bureau of animal Industry for registration and renewal of products

· Monitors and ensure validity of all Registered Licenses to Operate and Accreditations, Certificate of Product Registration and Exemption/ Clearance of products from appropriate government office/s

· To renew and ensure validity of Medical Director and Managing Director’s Licenses

· To assist acquisition of import permit for imported products

· To review packaging materials for printing

· To review posting of medical advertisement and subscription

· To initiate recall of products in case ordered by the manufacturer, handling of product complaints and monitoring/auditing of toll manufacturer

· To coordinate with the manufacturer regarding product registration and analysis

· Act as representative in meeting and seminars concerning regulatory functions

· Ensure GMP compliance of the company

· Conduct GMP training to new and regular employees associated to Good manufacturing and distribution Practice

· To ensure that all trademarks of the company are applied and declared the actual use

· Custodian of product dossier, manuscript and regulatory correspondence

· To assist in administrative functions in the office

TRAINING REQUIRED

· FDA GMP and licensing training

Skills

· Microsoft Office

· Above average communication skills

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