Plan, organize and implement regulatory strategies and required activities to ensure B. Braun products introduced in Taiwan market in a timely manner.
Being a trusted professional regulatory business partner to commercial and cross functional teams by providing value-added regulatory comments (inputs) and solutions from pre- to post market product lifecycle.
Be sensitive on applicable laws and regulations and proactively evaluate and determine impact on company activities.
Strategic decision and proposal in terms of responsible regulatory affairs submission related work. Empower to plan and decide time and data for submission.
Empowerment for regulatory liaisons and data offering to B. Braun internal, Taiwan government, health authority and regulatory related agencies within own authority of products.
Ensure approvals of registration, amendments and renewal of business product licenses, Drug Master File and Quality System Documentation/ Plant Master File are achieved in a timely manner in accordance with company objectives.
Prepare applications for the permits, licenses, certificates, authorizations, labels, and other approvals that the organization needs to conduct its business activities; and produce, sell, and distribute its goods and services. These may include product licenses, manufacturing, import and export permits. Sometimes also need to study and provide Taiwan regulatory opinions and appropriate solutions to the company in terms of regulatory related inquiries from local or global.
Per business needs, to handle and ensure approval of import permits, completion of health authority stamp process after expiration or amendment and regulatory medical review for promotional or advertising marketing materials in a timely manner.
Maintain license databases and product master file.
Proactively participate business discussions particular in product development (but not limited to) and provide advice to commercial, finance and other related departments on outlining registration component needs, timing and viewpoints.
Generate the regulatory strategies in responsible business product lines by communicating with commercial team and global regulatory affairs personnel incorporated as part of the commercial teams portfolio management process (new product launch plan and existing product assortment management plan).
Assess the impact of product changes including product label update from global notification and conduct corresponding regulatory required actions.
Liaise with Global Regulatory Affairs colleagues and Local/Regional/Global Sales & Marketing for regulatory affairs activities
Document and maintain the product dossiers, certification applications and filings required for operation management.
Provide regular registration status reports and present the rationale and following action plan to the Leadership team.
Liaise with government officials or agencies for regulatory standards, close monitor all the related official notifications in TFDA website and the meeting minutes which output in the industry association, and then evaluate the impact on the B. Braun business and prepare related procedures/documents accordingly including communicating changes with internal and external in a timely manner.
Create or update local Regulatory Affairs related Standard Operating Procedures in full compliance with current local regulations and company policies.
Assist the area in relation to processes of product qualification and certification with government regulatory agencies.
Provide expertise inputs and cowork with that organization members when involving projects or activities in industrial associations or societies and also share current industrial information with company internal.
Assist in Quality Management, Market Access and Government Affairs related document generation, process or communications.
Assist in internal/external audits, and participate in the audit team.
Deliver regulatory affairs related knowhow or regulation/policy trainings to B. Braun cross-functional colleagues if necessary.
When being in charge of regulatory affairs of control drugs, handle the control drug management, including apply the control drug import permit, cowork with internal department and 4PL provider for assure the selling amount and inventory always alignment, conduct authority system maintenance per control drug related regulation.
When being in charge of regulatory affairs of control drugs, as the representative contact window for communicate with competent authority for manage the control drug case, such as the discrepancy handling, destroy handling.
When being in charge of regulatory affairs of pharma products, manage the government system (ex: fadenbook), ensure all the upload information (drug outward appearance, Directions for Use (DFU), label) is up-to-date.
When being in charge of regulatory affairs of pharma products, support the business listing required Chemistry Manufacturing & Controls (CMC) documents.
Actively think and work on solutions cross Global and Local departments with company holistic perspectives to achieve the company maximum benefits
Proactively provide suggestions and solutions to areas for improvements or to streamline work processes.
The job function listed is not exclusive and shall also include any responsibilities as assigned by the Supervisor from time to time.
