Registration Department

| 8 minutes

The purpose of this document is to describe the functions of the Registration Department inside AdvaCare Pharma organization and define the department members' roles and responsibilities within the team.

1. KPIs

  1. Meeting registration deadlines
  2. Documentation accuracy
  3. Price Competitiveness (of relevant registration agents)
  4. Success rate (Resolved situations/Difficult registrations)

2. Organizational Structure

3. Department Role within Company

Goals of Registration Dept.
  • Prepare and manage the documents needed for registration of certain products in certain markets to help the company enter new markets and improve distribution in existing markets.
  • Contribute to shared knowledge of the Registration Dept.
  • Maintain up-to-date information of Vendor and Agent Documents, Agreements, Price List and other Regulatory background information in the Server and ERP.
  • Communicate with Vendors to get the required information or documentation to fulfill the registration requirements in the most time effective way.
  • Communicate with Agents related to the registration process to fulfill the registration requirements in the most time effective way and competitive pricing.
  • Assist Business Development Dept. by providing the information required to successfully register the products in a certain market.
  • Assist Business Development Dept. by sharing knowledge in regulatory/documents related issues.
Interdepartmental Relationships
Registration & Business Development Dept. (Sales Dept.)

The main role of BD Dept. is to develop new clients and handle registrations. BD Dept. identifies the registration needs of the clients and passes them over to Registration Dept. to offer possible solutions to satisfy clients’ registration needs.

The main challenge of BD Dept. is to find balance between what the company can do and what the importing country requires, and start the registration with maximum products. While Registration Dept. represents the vendors and their possibilities and needs, Sales Dept. represents the clients and the needs of the importing country. At the same time, both departments represent the company’s needs.

Representing different sides of the International Trade can be challenging and cause some friction, or even conflicts, between departments. However, balancing the needs of a client, vendor and the company is the key to company’s growth, therefore every member of both departments needs to be clear on the main goal: maximizing the profit of the company.

To keep the balance, Registration Dept. is responsible to:

  • Reply to all tasks sent by BD Dept., and every question asked via tasks within the least possible amount of time.
  • Provide maximum possible information and all options;
  • Provide the documents for registration within the least possible amount of time and make sure the deadlines are met;
  • Not just copy/paste the information, but think what option will be best for the company and share opinion or advice when possible;
  • Facilitate inter-department communication.

BD Dept. is responsible to:

  • Get all the details about the products and required documents from the client and provide the information to Registration Dept. beforehand.
  • Be clear on the specifications of products required.
  • Filter out the clients that will not be able to complete the registration and make an order afterwards to avoid registering products that will never be ordered, which not only wastes time but also spoils the relationship with Vendors.
  • Be clear on when the client intends to start the registration to get the documents from Vendors on time.
  • Facilitate inter-department communication.
Registration & Account Managers (Sales Dept.)

The main role of Account Managers is to develop existing clients. In the situation when an existing client intends to place and order and start simple registration for the same products at the same time, Sales Dept. identifies the registration needs of the clients and passes them over to Registration Dept. to source the vendors and offer possible solutions to satisfy country requirements.

The main challenge of Sales Dept. is to find balance between what the company can do and what the client wants, and start the order with maximum products and maximum profit possible. While Registration Dept. represents the vendors and their possibilities and needs, Sales Dept. represents the clients and the needs of the importing country. At the same time, both departments represent the company’s needs.

Representing different sides of the International Trade can be challenging and cause some friction, or even conflicts, between departments. However, balancing the needs of client, vendor and the company is the key to company’s growth, therefore every member of both departments needs to be clear on the main goal: maximizing the profit of the company.

To keep the balance, Registration Dept. is responsible to:

  • Reply to all tasks sent by Sales Dept., and every question asked via tasks within the least possible amount of time.
  • Provide maximum possible information and all options.
  • Not just copy/paste the information, but think what option will be best for the company and share opinion or advice when possible.
  • Facilitate inter-department communication.

Account Managers are responsible to:

  • Get all the details about the products and required documents from the client and provide the information to Registration Dept. beforehand.
  • Be clear on the specifications of products and required documents and inform Registration Dept.
  • Be clear on when the client intends to start the order and registration to get the documents from Vendors on time.
  • Facilitate inter-department communication.
Registration & Procurement Dept.

The main role of Procurement Dept. is to identify a Vendor that can satisfy the needs of the client and importing country. Sales Dept. instructs Procurement Dept. of the requirements and Procurement Dept. works on finding the Vendor that can provide the needed products and documents.

Procurement Dept. will identify the Vendors for any given RFQ, and once the RFQ is confirmed and Vendors are identified Registration Dept. will take over to handle the documentation with the selected Vendors.

Procurement Dept. is responsible to:

  • Identify the Vendors and inform Registration Dept. which Vendors are final.
  • Assist Registration Dept. with pushing the Vendors to provide the documents in time, when necessary.
  • Provide any other information that can be useful for Registration Dept.

Registration Dept. is responsible to:

  • Communicate with Procurement Dept. to know the situation of each Vendor;
  • Communicate with Vendor to get the required documents;
  • Prepare the required documents when necessary;
  • Make sure the documentation is provided on time.
Registration & Design Dept.

The main role of Design Dept. is to prepare packaging artwork for the products confirmed for registration.

Registration Dept. is responsible to:

  • Check the specification of every new product confirmed for registration.
  • Inform Design Dept. through Salesperson (tasks are not to be sent directly to the Design Dept.) of any inconsistencies between the documents and artwork designs.

Design Dept. is responsible to:

  • Prepare the artwork designs on time.
  • Follow specifications instructions provided by Registration Dept. that have been approved by Salesperson.

4. Roles and Responsibilities

Registration Dept. Supervisor

General:

  • Assigning registration tasks and workload within department;
  • Supervise the work and performance of Registration Specialist;
  • Identify potential problems of registrations;
  • Advise preferred course of action for registrations and predict possible difficulties;
  • Make sure Registration Dept. meets the deadlines;
  • Resolve problems during the registration process;
  • Prepare, review and/or revise registration documents;
  • Data maintenance in Odoo and Server;
  • Provide technical support for Sales and Procurement Dept.;
  • Provide technical support related to the research and development of new products;
  • Ensure efficient communications between Vendors/Agents and Reg. Dept.;
  • Ensure the quality and price competitiveness of vendor/agent documents.

Deliverables:

  • Dossiers, other registration documents
  • Registration Certificates
  • AdvaCare SOPs
  • Updated Milestones, RA, PRs, Documents on the ERP (Registration Module)
  • Updated Server database (Authentication cost G-sheet, organized registration related folders)

Documents:

  • AdvaCare SOPs
  • Registration document templates and MOH guidelines
  • Vendor Registration Agreement templates
  • Registration Work Status Sheet

Skills:

  • Decision-making
  • Problem-solving
  • Delegation
  • Accuracy
  • Attention to detail
  • English language
  • Knowledge of various dossiers formats
  • Understanding of the process of drug development, production and analysis
  • Understanding of the pharmacological and toxicological effects of drugs
  • Communication skills: to obtain required documents from vendors, efficient transactions with agents, comprehensive feedback to other departments within the company
Registration/Purchasing Specialist

General:

  • Process registration RFQs: identify possible manufacturers, contact manufacturers, provide prices, conditions and terms, any other additional information from Vendors + detailed information about documents required for registration;
  • Process Registrations: assist Sales Dept. with finalizing the Vendors, get the registration samples (if needed), prepare the necessary documentation (Documents and Samples agreement, CPA, NDA, Registration Agreement, etc.), coordinate with Sales and Registration Dept. in providing any additional information;
  • Communication with Vendors and Agents, follow up on registration related documents;
  • Ensure the quality and price competitiveness from Vendor/Agent;
  • Sourcing new Vendors and Agents;
  • Prepare, review and/or revise registration documents;
  • Maintain Vendor information in the System (Vendor page: catalog, contact information, Chinese translations, available documents);
  • Maintain Vendor information in the Server (copies of any certificates, documents or agreements from the Vendor in the manufacturer folder);
  • Registration data maintenance in the System (Registration Module: Updated Milestones, RA, PRs, Documents);
  • Registration data maintenance in the Server (Updated Server database of authentication cost G-sheet, organized registration related folders);
  • Work on any other project or assignment given by Dept. Manager.

Deliverables:

  • Dossiers, other registration documents
  • Authenticated documents
  • Registration Certificates
  • Quotations from Vendors
  • Purchase Order for samples
  • Registration Agreements and other Vendor/Agent related agreements
  • Updated Milestones, RA, PRs, Documents on the ERP (Registration Module)
  • Updated Server database (Authentication cost G-sheet, organized registration related folders)

Documents:

  • AdvaCare SOPs
  • Registration document templates and MOH guidelines
  • Vendor Registration Agreement templates

Skills:

  • Knowledge of various dossiers formats
  • Understanding of the process of drug development, production and analysis
  • Understanding of the pharmacological and toxicological effects of drugs
  • Accuracy
  • Attention to detail
  • English language
  • Communication skills
Registration Assistant

General:

  • Prepare, review and/or revise registration documents;
  • Resolve document problems during the registration process;
  • Legalization/notarization of documents;
  • Make sure to meet registration deadlines;
  • Provide technical support for other departments
  • Data maintenance in Odoo;
  • Ensure efficient communications with Vendors/Agents and Reg. Dept.;
  • Ensure the quality and price competitiveness of vendor/agent documents.

Deliverables:

  • Dossiers, other registration documents
  • Registration Certificates
  • Updated Milestones, RA, PRs, Documents on the ERP (Registration Module)
  • Updated Server database (Authentication cost G-sheet, organized registration related folders)

Documents:

  • AdvaCare SOPs
  • Registration document templates and MOH guidelines
  • Vendor Registration Agreement templates

Skills:

  • Knowledge of various dossiers formats
  • Understanding of the process of drug development, production and analysis
  • Understanding of the pharmacological and toxicological effects of drugs
  • Accuracy
  • Attention to detail
  • English language
  • Communication skills
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