Executive, regulatory affairs

1 month ago

Singapore B. Braun Melsungen AG Full time

You’re an important part of our future. Hopefully, we're also a part of your future At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency, and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency, and appreciation. That's Sharing Expertise. Job Title: Executive, Regulatory Affairs Job Posting Location: SG-Singapore 600 N Bridge Rd Functional Area: Regulatory Affairs Working Model: Hybrid Job Purpose: Request, compile and submit complete product registration application documents in accordance with regulatory requirements; Follow up with product registration applications submitted until product license approval is obtained; Be informed of current regulatory requirements and updates; Role and Responsibilities: Full awareness of local Health Products and Pharmaceutical Acts and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; Communicate changes and new requirements to management; Request and submit documents for product registration and amendments applications; Follow up on submitted applications and reply to input requests from the authority; Meet, discuss, and negotiate with HSA regulators on matters pertaining to product registrations; Have working knowledge of current products sold and keep abreast of new product launches by having regular update meetings with all the selling division managers; Assist Assistant Manager, Regulatory Affairs for matters pertaining to regulatory affairs as and when required; Communicate with AP RA, Global RA, and manufacturers, the local regulatory requirements, in order to facilitate the provision of appropriate documents for submission to HSA for product registration/amendments and compliance to local regulations; Comply with reporting requirements of AP RA and Global RA; Regulatory reporting for recalls, FSCAs, Adverse Events, and complaint handling; Ensure compliance with GDP and GDPMDS; Ensure conduct of business according to local regulations for pharmaceuticals, medical devices, cosmetics, and enteral nutrition; Participate in internal and external audits (e.g., GDP, GDPMS); Maintain and update regulatory-related databases and SOP; Registers complaint on SAP/C3 and sends complaint form together with samples to manufacturer. Follow-up on replies from manufacturer. Updates status on SAP/C3; Provides cooperation to the Safety Officer medical devices/drugs (SO MD/DSO) for handling of product risks; Minimum Requirements: General Degree; Preferred 1 year working experience or completion of Internship in the related field; Licensed pharmacist preferred; Familiar with local regulatory affairs requirements (pharmaceutical/medical devices); Good interpersonal relationship skills; Good organization skills; #J-18808-Ljbffr

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