Jr. FDA Regulatory Affairs Officer
Department/Company: Legal Compliance
Number of Vacant Position/s: 1
Requirements (Hybrid Set-Up):
- Open to licensed/not licensed pharmacist
- Knowledgeable in PH FDA/BFAD/DOH procedures, regulations and processes
- With at least 2 years work experience as a Regulatory Officer in a pharmaceutical industry
- Must have excellent communication and interpersonal skills
- Detail oriented, adaptable, ability to work independently
- Must be assertive, confident and dynamic
- Computer literate and can work under minimum supervision
- Willing to work in BGC
Job Description:
- Works with FDA/BFAD/DOH on product registration and other regulatory requirement needed to support the clients
- Ensures that LTOs, CPRs of drug/cosmetic products are up to date and in compliance with the regulatory requirements of the Food and Drug Administration (FDA)
- Coordinate, compile, organize, and review client’s documents for pre-submission to FDA
- Monitor and maintain necessary recordkeeping on new regulations, regulatory information and other regulatory issues;
- Interpret regulatory rules or rule changes and ensure that they are communicated with the potential clients, existing clients, and legal compliance manager
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Compile and maintain regulatory documentation databases or systems and fill-out the FDA client and inquiry tracker shared with the LCD manager
- Preparation and submission of document to FDA/BFAD/DOH such as LTO and CPR
- Support and promote good relation with regulatory institutions and its practices and other related organization
- Ensure that all FDA licenses, and permits are updated and valid
- Maintain and update all files related to product registration and other regulatory requirements.
- Properly file, monitor and closely follow-up statuses of applications in the abovementioned regulatory bodies
Visa Specialist
Department/Company: Immigration Services
Number of Vacant Position/s: 1
Requirements (Hybrid Set-Up):
- Candidate must possess at least a Bachelor’s degree/college degree in Legal Management, Business Studies / Administration / Management, others or equivalent.
- With 1 to 2 years of related work experience in law or corporate setup.
- Excellent written and verbal communication skills with proven ability to communicate effectively over the telephone, face to face interactions and documentation (via email and drafting & proofreading of documents).
- Willingness and ability to work under pressure and fast-paced cross-cultural environment.
- Excellent time management and organizing skills.
- Extremely detail oriented well regimented in handling simultaneous tasks.
- Willing to work in BGC
Job Description:
- Assists foreign national and company representatives with immigration policies and procurement.
- Ensure all paperwork including applications for Immigration and visas completed accurately and in a timely manner.
- Tracks visa and work permits progress through the “visa monitoring tracker” by keeping it updated.
- Communicates with various government agencies for certification of documents and coordinates with third parties on documentation needs.
- Works with Manager, liaison officer and colleagues to complete work permit, residency and visa documentation.
- Performs other duties assigned
Submit your resume to erica@incorp.ph
Please include the position you are applying for in the subject of the email.
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