Regulatory Affairs Manager

Responsibilities

• Ensures regulatory compliances in the distribution of pharmaceutical and healthcare products where Zuellig is the marketing authorization holder (e.g., manages and checks monitoring of validity of Certificates of Product Registration (CPRs) and other authorizations)
• Represents Zuellig in various engagement Regulatory Health Authorities
• Executes key regulatory actions to support business requirements.
• Ensures adherence to current and new regulations
• Provides support to medical affairs in submission, reporting and documentation of Clinical Trials
• Supports Medical function in Pharmacovigilance reporting to FDA
• Implements Corrective & Prevention Action
• Interacts with Philippine FDA and other regulatory bodies on product registration matters
• Prepares and reviews regulatory filings prior to submission
• Communicates & coordinates with clients regarding requirements on product registration (initial, renewal, amendments, GLE, clinical)
• Reviews labels and claims in packaging artworks, including stickers, and product inserts
• Monitors compliance of all product labels and claims in packaging artworks according to approved standards
• Review promotional materials and programs and advertisements and direct to consumer campaigns
• Cascade relevant and new regulations from governing bodies
• Review and approves documents and ensures adequate regulatory support to hospital formulary listing and bidding
• Prepares regulatory proposal including costing for new businesses
• Engages with the region on In-License brands regulatory requirements
• Coordinates the investigation on product complaints with clients.
• Provides product release disposition for products where we are MAH if required
• Approves the repackaging work instruction based on Packaging Materials Reference Standard for secondary repackaging activity

Qualifications

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Health Care Provider and Quality Assurance

Industries

Pharmaceutical Manufacturing

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