Regulatory Affairs Associate Manager (Hanoi, Hoan Kiem and Ba Dinh, VN)

JOB MAIN PURPOSE

The position will have responsibility for execution Regulatory Affairs activities under RA Lead instruction for the company compounds in Vietnam in order to achieve and maintain registrations in line with the short-term and long-term commercial objectives of Bayer Pharmaceuticals Division and in compliance with all relevant regulatory and legal obligations

To partner with relevant stakeholders to assist in achieving optimal company outcomes

YOUR ROLE & RESPONSIBILITIES

Coordinate with Global RA partners to execute routine registration activities for portfolio assigned (including new registration, renewal and variations) such as

timely request registration dossier and other necessary documents where needed

prepare registration dossiers

ensure regulatory compliance for life cycle management including evaluation and implementation of manufacturing and labelling changes in accordance with local regulations and relevant Bayer SOPs

Involve in relevant regional/global meetings and cross-functional meetings related to project when required.

Coordinate with CQH to manage product complaints and recall process, including health authority interaction and communications. Provide necessary documents to enable CQH to complete local compliance checks

Responsible in maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted for assigned products.

Liaises closely with MOH, local industry and other regulatory agencies to establish and maintain effective communication with them.

Monitor regulatory environment and competitor regulatory activities for portfolio assigned. Assess impact and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit

Takes responsibility in reviewing promotional materials that are relevant to assigned therapeutic area when requested by material’s owner

Support tender by update EU/PIC GMP listing, original product list and provide other necessary RA related documents

VALUE ADDED TO THE SUCCESS OF THE COMPANY

 

Responsible for Regulatory submissions and approvals for products assigned, enabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.

Provides input and insights for regulatory probability assessments, anticipating these changes based on experience and knowledge of the environment.

Building relationships with the Health Authorities, as key customers, is essential for achieving business goals. The relationship is based on trust, transparency and partnership and is clearly a major focus of this function.

Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight

Maintain system for archiving regulatory documentation with easy access to regulatory history and regulatory documents

Secure and maintain compliant product licenses, product labelling and participate in promotional material review/approval for a product range

Provide timely, high-quality support, incl. regulatory information to the relevant local functions and regulatory team

YOUR KEY SKILLS & QUALIFICATIONS

Have medical or pharmaceutical background with a minimum of 3-5 years pharmaceutical industry experience in regulatory affairs

Have capability to work independently and cross functionally

Have good communication skills

Fluent in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills.

Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.

Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function.

Thorough knowledge of company policies and procedures. Detailed understanding of the process and policies of the national or agency or extensive experience with a related national health authority.

Profound knowledge of local regulations and applicable legislation including regulatory requirements and regulatory framework related to registrations and post-approval variations

Meticulous

Good time management skills

Application Period: 15 Oct - 30 Oct 2026 Reference Code: 892987     Division: Pharmaceuticals   Location: Vietnam : Hoan Kiem and Ba Dinh : Hanoi     Functional Area: Regulatory Affairs   Position Grade:     Employment Type: Regular  Work Time: Standard       Contact Us   E-Mail     tam.nguyen2.ext@bayer.com               ]]>