Regulatory Affairs pharmacistSt. Tyke Inc.

Responsibilities: * Represent the company as the registered Pharmacist
Ensure company's compliance to FDA regulations which includes application of License to Operate (LTO) and product registration
Ensure validity of all regulatory documents such as LTO, product registration, regulatory requirements per product, supplier's agreement, and other company licenses such as the Business permit and Bureau of Customs Registration
Ensure all products are labelled in compliance to the FDA regulations
Update management on FDA concerns; disseminate FDA information and directives to the management
Prepare, compile, and submit all the necessary documents to applicable regulatory agencies until completion
Prepare all the documents for hospital biddings and similar activities
Conduct personnel training to enhance knowledge on good distribution/storage practices
Implement regulatory and statutory requirements to company processes and activities
Coordinate with the company's customs broker to facilitate smooth delivery of imported stocks to warehouse
Handle product complaints if there are any
Responsible in filing confidential documents related to the products for safekeeping
Coordinate with foreign and local manufacturers regarding regulatory matters
Salary Expectation (range):
- P25,000.00 - P35,000.00 (depending on experience)
- Transportation Allowance and Per Diem
- Performance Incentives
- Annual Performance Bonus
Qualifications:
Ø Must be a registered Pharmacist with a valid PRC license
Ø At least 2 years of experience in regulatory or any related field is preferred
Ø Willing to work in Makati
Skills:
Ø English proficiency
Ø Good verbal and written communication skills
Ø Tech savvy
Ø Great interpersonal skills
Ø Organized and resourceful
Ø Resilient with excellent problem-solving skills
Ø Can work with minimum supervision
Bossjob

Makati City, Metro Manila
₱25,000-35,000 per month
Permanent
Full-time