(sr.) regulatory affairs associate

4 weeks ago

Central And Western District, Hong Kong SAR China Bayer Full time

(Sr.) Regulatory Affairs Associate (1 year contract)5 days ago Be among the first 25 applicants Responsible for regulatory activities for the assigned portfolio for commercial products, life cycle management initiatives for Hong Kong and Macau. Responsible for regulatory activities for the assigned clinical trial products, life cycle management for Hong Kong. Delivers RA milestones for Hong Kong and Macau. Act as functional expert on projects assigned. Bring RA expertise into submission strategies to realize and accelerate business strategy. Provide strategic regulatory planning, regulatory requirement for clinical studies and marketing approval, risk assessment, issue management. Ensure successful implementation and execution of regulatory plans to support product approval and commercialization. Provide regulatory inputs on local regulatory strategic and operational matters to fulfill local business strategies for the assigned portfolio. Responsible for regulatory compliance. Establish and maintain excellent working relationships with local regulatory agencies. Provide regulatory support on product supplied to government sectors. Ad-hoc projects assigned by Head of Regulatory Affairs. POSITION REQUIREMENTS: Bachelor’s degree in health-related science/Pharmacy/Medical degree.1-2 years pharmaceutical industry experience in regulatory affairs, with at least 1 year in pharmaceutical drugs and/or biologicals. Experience and regular use of Microsoft Office applications including Word, Excel, Outlook, Teams, and Power Point, to at least an intermediate level. Excellent English and Chinese communication skills (both Cantonese - oral and traditional Chinese - written). Able to communicate effectively in English to convey (complex) technical information to regional/global area experts and be able to discuss/present expert matters confidently. Well organized, pleasant, proven ability to work effectively to meet deadlines, proactive, proficiency in problem-solving as well as good interpersonal skills. Able to work widely autonomously with minimal supervision. Proven track record of managing regulatory applications to successful outcomes across various types of applications, including CMC and labelling variations in HK and Macau. Proven track record of coordinating variation implementation in HK and Macau. In-depth technical regulatory knowledge in at least one therapeutic area, including pharmaceuticals and/or biologicals would be an advantage. Able to evaluate regulatory documents and determine appropriate action and able to provide regulatory assessment to other departments with little or no supervision. Knowledge of local legislations (CAP138, CAP132, CAP231, CAP137). Seniority level Associate Employment type Contract Job function Quality Assurance and Other Industries Pharmaceutical Manufacturing#J-18808-Ljbffr

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