Job Description

JOB DESCRIPTIONJob SummaryThe Regulatory Head is responsible for the compliance of the company to all regulatory requirements by the Food and Drug Administration (FDA).Key Accountabilities Prepares and submits application of initial / renewal registration ad secures these regulatory licenses and documents required by FDA including Certificate of Medical Device Registration (CMDR), Certificate of Medical Device Notification (CMDN) and License to Operate (LTO). Coordinates with the suppliers / Foreign principals for the required documents in the application of initial / renewal of these licenses / registration. Keeps record of all certificates / licenses and ensures that all are valid and updated. Ensures that the company complies to the requirements of FDA in the storage, handling and distribution of medical devices. Reports all product-related customer feedback to the suppliers / principals together with the Marketing department. Coordinates with the Sales, and Marketing teams for the products intended for registration application. Secures all required CME's for the maintenance of pharmacist license. Submits weekly accomplishment report on status of FDA applications. Performs other related duties as required and assigned.Attributes Knowledge in regulatory processes and requirement. Knowledge and understanding of relevant legal, scientific and manufacturing areas Team player and helps in building positive working environment. Job task planning and organizing. Ability to manage time and resources. Ability to work under pressure. Willingness to extend working hours. Microsoft office and computer use.Experience & Knowledge

• Graduate of BS Pharmacy, BS Chemistry, BS Physics, BS Biochemistry, life or applied Science or other related course.
• At least 1 year of working experience as regulatory.
• Must be Registered Pharmacist or related degree.

Job Types: Full-time, PermanentSalary: Php18,000.00 - Php25,000.00 per monthSchedule:

• 8 hour shift

Supplemental Pay:

• 13th month salary

Ability to commute/relocate:

• Quezon City: Reliably commute or planning to relocate before starting work (Required)