Regulatory Affairs Associate Manager

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Job Description | | || - | - | - | - | - | - || | | - | | | | | | || | | | | || | | | | || | | | | |
** 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…