Description
Duties and Responsibilities:
Propose and implement effective strategies to minimize the timing of and optimize the commercial viability of product licenses from the relevant regulatory body.
Ensure product licenses are up to date and fully compliant.
Maintain strong relationships with all personnel within the relevant regulatory body to ensure ease of access and influence.
Identify and analyze key regulatory issues impacting the Company's dietary supplements and drugs and make recommendations for strategic solutions.
Evaluate regulatory risk and strategy for proposed new products and ingredients and manage, monitor, and support FDA filings as required.
Liaise with QA/QC, R&D, Legal, Marketing, and general management to address regulatory issues affecting product sales. Review and revise Company policies, procedures, and SOPs that impact regulatory compliance.
Manage and/or participate in inspections of Company facilities by the FDA and other applicable agencies.
Provide regulatory input on product development.
Oversee the preparation of regulatory-mandated label copy for dietary supplements, to meet various regulations.
Proofread and approve labels based on an understanding and interpretation of product formulas, contract provisions, account preferences and, applicable regulation policies.
Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.
Requirements
Minimum education level: Bachelor ́s Degree
Years of experience: 1
Language(s): English ,Tagalog
Availability for travel: No
Availability for change of residence: No
People with disabilities: Yes
Duties and Responsibilities:
Propose and implement effective strategies to minimize the timing of and optimize the commercial viability of product licenses from the relevant regulatory body.
Ensure product licenses are up to date and fully compliant.
Maintain strong relationships with all personnel within the relevant regulatory body to ensure ease of access and influence.
Identify and analyze key regulatory issues impacting the Company's dietary supplements and drugs and make recommendations for strategic solutions.
Evaluate regulatory risk and strategy for proposed new products and ingredients and manage, monitor, and support FDA filings as required.
Liaise with QA/QC, R&D, Legal, Marketing, and general management to address regulatory issues affecting product sales. Review and revise Company policies, procedures, and SOPs that impact regulatory compliance.
Manage and/or participate in inspections of Company facilities by the FDA and other applicable agencies.
Provide regulatory input on product development.
Oversee the preparation of regulatory-mandated label copy for dietary supplements, to meet various regulations.
Proofread and approve labels based on an understanding and interpretation of product formulas, contract provisions, account preferences and, applicable regulation policies.
Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.
Requirements
Minimum education level: Bachelor ́s Degree
Years of experience: 1
Language(s): English ,Tagalog
Availability for travel: No
Availability for change of residence: No
People with disabilities: Yes
Other Info
Cavite, Calabarzon · 3 minutes ago
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Philippine United Pharma Corp.
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Philippine United Pharma Corp. jobs
Cavite, Calabarzon · 3 minutes ago
Position Regulatory Pharmacist recruited by the company Philippine United Pharma Corp. at , Joboko automatically collects the salary of , finds more jobs on Regulatory Pharmacist or Philippine United Pharma Corp. company in the links above
About the company
Philippine United Pharma Corp. jobs
Cavite, Calabarzon · 3 minutes ago