Regulatory Pharmacist
Makati, National Capital Region
Posted 2 days ago
- Company:
- Dempsey Local Employment Direct Hire Management
- Company Description:
- We are an executive search company engaged in the sourcing and referral of college graduates and professionals in the fields of Accounting, Finance, Engineering, Sales, Marketing, Web & Programming, HR & Admin, Behavioral Science, Arts and related fields.
- Contract Type:
- Full Time
- Experience Required:
- 2 years
- Education Level:
- Bachelor’s Degree
- Gender:
- Any
- Number of vacancies:
- 1
Job Description
Location: Makati & Batangas
QUALIFICATIONS
Licensed Pharmacist and familiar with FDA and PDEA ruling
With more than 2 years of work experience in the field of Regulatory
Possesses good interpersonal and communication skills
Attentive to details, analytical, and result-oriented
Excellent oral and written communication skills
Responsible for ensuring the compliance of the documents per FDA Guidelines for the Initial Applications for Medical Device & Drug Applications upon submission to the FDA to merit approval and secure a Certificate of Product Registration.
Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Medical Device Initials, and Notifications.
Responsible for renewal and revalidation of LTO & Certificate of Product Registration
Communicates with the suppliers, evaluates and prepares the requirements for CMDN/ CMDR submission.
Responsible for variation/amendment applications of Certificate of Product Registration.
Responsible in having follow-ups for the applications that were not yet evaluated by FDA
for timely release of approval from FDA.