Regulatory Affairs Associate

ACCOUNTABILITY OBJECTIVE:

Ensures FDA compliance of the company's application and renewal permits. This position is also accountable for monitoring company products inventories through in-depth consideration of the date input of every transaction.Regular conduction (bi-weekly and monthly) of product and product sample inventory is for strict implementation. Product development and research aligned with the Sales and Marketing's objectives are likewise critical.

DUTIES AND RESPONSIBILITIES:

1.REGULATORY FUNCTION

a.Maintains updated documents and process FDA application and renewals as required in the company's activities such as:

i.License to Operate as Importer, Distributor, Wholesaler (Food & Drug), etc.

ii.Certificate of Product Registrations

iii.Promotional Permits and other required licenses and permits

iv.Variations & notifications related to product and company as necessary

v.New product initial registration

vi.Process authentication of documents as needed

b.Represents the company during FDA audit:

i.Ensures complete and updated files of documents related to FDA inspection/s.

ii.Addresses deficiencies and compliances as noted during inspection/s.

c.Ensures EDPMS reporting to DOH.

d.Attends to seminars/training and ensure the company is abreast with current regulatory policies and requirement.

e.Maintains and coordinates renewals of company contracts such as:

i.Distributorship Agreement with Foreign and Local Suppliers

ii.Contract of Lease for office/s and warehouse

2.IMPORTATION/LOCAL PROCUREMENT

a.Coordinates with Foreign andLocal Suppliers and Diamond Laboratories, Inc. matters such as:

i.Product Quality

ii.Availability of Stocks as to Purchase Orders, Delivery & Shipment.

iii.Permits & Licenses such as CPR, LTO, GMP Certificates, Product Certificates of Analysis, etc.

b.Ensures complete and updated filing of documents such as:

i.Proforma Invoices, Packing List for imported products.

ii.Sales Invoices and Delivery Receipts for locally procured products.

c.Coordinates and addresses Customer Complaints, Product Recall, Returned Goods (RGS), Product Rejection concern both with Costumer and Suppliers.

d.Oversee and/or coordinates with supplier product repacking/reprocess as necessary.

3.Oversee compliance to Good Storage, Distribution Practices and Product Compliance as to FDA & PIC/s guidelines:

a.Ensures product compliance to the approved registration i.e labels/packaging.

b.Ensures proper and safe storage of products as required.

c.Ensures correct distribution and proper transport of products.

d.Ensures correct records/files of Sales Invoices and/or delivery receipts. Information such as Costumer Name, Address, Product Name, Lot & Expirations are complete.

e.Ensures correct and updated records of Sales and Distribution.

f.Ensures good housekeeping and maintenance of warehouses including environmental monitoring such as temperature, pest control etc.

4.SALES & MARKETING

a.Ensures compliance of the company's sales, marketing and promotion activities to FDA regulations.

b.Works with Marketing personnel on the monitoring and implementation of promotional activities and programs.

c.Conducts training and provides product knowledge to Sales and merchandising personnel.

5.PRODUCT DEVELOPMENT

a.Performs extensive and substantial product research and studies as required by the Operations Manager and/or as directed by the Management.

6.Develops and recommends relevant policies and procedures (SOPs) as required for proper and efficient company operation, in reference to Philippine FDA restrictions.

7.INVENTORY & SUPPLIES CUSTODIAN

a.Physical count of all products at least twice a month and ensure proper level of supplies

b.Checking of all delivered products upon unloading

c.Office supplies procurement on a quarterly basis

d.Ensure completeness of all accountable forms (Marketing & Actg forms)

e.Ensures good housekeeping and maintenance of warehouses including environmental monitoring such as temperature, pest control, etc.

8.Accomplish reports/updates regularly and performs other duties as required by the Operations Manager and/or Management.