Regulatory Affairs Executive

I. Position purpose: A brief statement indicating the basic purpose of the position

1. Responsible for the timely registration of new products of the Business group and the renewal registration of current products.

2. He/She is expected to regularly visit the regulatory authorities and report on any development that may affect the business.

3. He/She is also be responsible for updating all BCH's regulatory databases.



II. Major tasks and responsibilities of position:

- Maintain registration of products intended for local marketing.

- Coordinates requirements from governmental agencies concerned for product initial registration/renewal and documentation.

- Fulfills medical and pharmaceutical certification, clearance of reclassification, promotional approval requirements requested by Marketing.

- Reviews text for labels, package inserts and other commerical product presentations for approval of RA Manager.

- Develops objectives and strategies on tasks to ensure implementation and successful achievement of all plans.

- Formulates together with line manager, individual performance objectives to enhance expertise, techinical skills and over all effectiveness.

- Ensures maintainance and upkeep of all regulatory affairs documents and internal reporting databases such as Brain, Synaps..

- Performs other duties required by line manager from time to time.



III. Value added to the success of the company - what are the main objectives of the function?

- Conducts technical review and assessment, prepares and submits to the regulatory authorities all pertinent documents related to product registration.

- Secures from Global Regulatory Affaris, other Bayer affiliates and from R&D the required documents and materials needed for ensuring local registrations.



IV. Work relations:

- External: Health authorities: Key Personnel in Drug Administration of Vietnam, Department of Medical Equipment and Construction, Vietnam Food Association - Ministry of Health

- Internal: Marketing and Sales Department, Medical and PV, Supply Chain, Quality Operations, Regional/Global Regulatory, RA peers, Legal Department, Communication Department.

- Provides regulatory support and guidance to colleagues in their procurement, marketing, sales and manufacturing activities to ensure compliance to relevant internal and external regulations.

- Assists marketing in development and documentation of product claims, text and promotional materials to comply with HA regulations.

- Develop and foster personal contact within HA and other pertinent agencies.

- Conducts competitive intelligence networking of products as necessary.

- Conducts training on relevant SOPs, Issues and laws, product information as necessary.

- Attend to queries related to product information.