Regulatory Affairs Officer (8 months)

Lương không công khai

Hà Nội

Nghỉ trọn T7, CN

Hạn chót 23/10/2026

Đăng 5 giờ trước

Hãy là ứng viên đầu tiên

Yêu cầu công việc

• Have medical or pharmaceutical background with a minimum of 1 years experience in the field of Regulatory Affairs. • Fluent in English and local language(s) • A team player • Strategic thinker and good analytical skills • Good interpersonal and communication skills • A high level of attention to detail

Công việc cụ thể là gì?

Purpose:Responsible for the timely registration of new products of the Business group and the renewal of registration of current products.Regularly visit the regulatory authorities and report on any development that may affect the business and are responsible for updating all Bayer Consumer Health's regulatory databases.Scope (global, regional or local):• Conducts technical review and assessment, prepares and submits to the regulatory authorities all pertinent documents related to product registration.• Secures from Global Regulatory Affairs, other Bayer affiliates & from R&D the required documents and materials needed for ensuring local registrations.• 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.Key Tasks:1. Maintain registration of products intended for local marketing.2. Coordinates requirements from governmental agencies concerned for product initial registration/renewal and documentation.3. Fulfills medical and pharmaceutical certification, clearance of reclassification, promotional approval requirements requested by Marketing.4. Reviews text of local product inserts (PIs), local Artwork in coordination with the internal approvers, consistent with agreed task ownership matrices.5. Develops objectives and strategies on tasks to ensure implementation and successful achievement of all plans.6. Formulates together with line manager, individual performance objectives to enhance expertise, technical skills and overall effectiveness.7. Ensures maintenance and upkeep of all regulatory affairs documentsand internal reporting databases.8. Performs other duties required by line manager from time to time. • Ngày làm việc: T2 - T6 • Giờ làm việc: 09:00 - 18:00 • Cấp bậc: Có kinh nghiệm • Loại công việc: Thời vụ

Bayer Vietnam Limited (Bvl)

Sản xuất

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. The Pharmaceuticals Division of Bayer focuses on prescription products for women’s healthcare, cardiology, oncology, hematology and ophthalmology. The division also comprises the Radiology Business Unit which markets contrast-enhanced diagnostic imaging equipment together with the necessary contrast agents. There has never been a more important time for innovation in agriculture. Our world faces enormous challenges -- from a changing climate, limited natural resources to a growing population. And we believe agriculture is part of the solution. At Bayer, we’re a responsible, global team working to shape agriculture through breakthrough innovation for the benefit of farmers, consumers and our planet. For more than a century, we have worked to solve some of the toughest problems in agriculture. In the face of an ever-changing climate, a growing population and limited resources, how can we grow more healthy, safe and affordable food in a sustainable way? From the Earth’s deepest roots to its highest satellites, we combine modern science with farmers’ ingenuity to put innovation at their fingertips that can to help nourish our growing world and preserve natural resources. And, while we don’t have all the answers, our passion for discovery, collaboration and curiosity means we will never stop striving to find them. Through our work, we’re committed to delivering better solutions for all farmers while enabling more choice for consumers to help them and our planet thrive.

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