Regulatory Affairs Associate
(2 years contract)

[Your Tasks and Responsibilities]

·        Manage planning and execution of regulatory affairs activities (e.g. preparation and submission of new registration, line extension, post-approval variations) and follow through from submission to approval.

·        Provide regulatory gap analysis and risk mitigation plan, timely communicate to local & regional RA management for assigned portfolio.

·        Ensures regulatory compliance for a sustainable life-cycle management: manage labeling and CMC changes in accordance with local regulations and relevant global SOPs

·        Ensure proper maintenance and update of product licenses in compliance with global standard and local regulations.

·        Review and approve packaging texts to ensure compliance with registration and legal requirements.

·        Maintain global regulatory databases accordingly, and archive registration dossier of assigned portfolio in accordance with global and local SOP.

·        Manage regulatory activities for clinical trials based on documentations provided from global regulatory affairs and in accordance with local regulations. 

·        Monitor and timely communicate upcoming regulation or policy changes for assigned area including preliminary impact analysis.

[Qualifications / Requirement]

·       Life Sciences based BS or MS with requisite experience and demonstrated track record.

·       Preferably more than 1 year's experience in regulatory or drug/biologic development experience in pharmaceutical industry.

·       Good in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills. Good cross-functional communication skills

·       Knowledge of local regulatory framework, compliance aspects related to regulatory affairs function and other relevant country requirements applicable to pharmaceuticals and medical devices is desired.