Regulatory Affairs jobs in Malásia

Job Level & compensation offered may vary depending on candidates’ experiences and competencies.

• Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
• Reviews study compliance against protocol, SOP and regulatory agency guidelines.
• Communicates and interacts with study team, other departments and clients as applicable.
• Assists in the development and maintenance of standard report/table formats as needed.
• Plans, prioritizes and manages own workload and multiple responsibilities.
• Independently use project tracking systems as appropriate.
• Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
• Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
• Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
• Assists in interpreting and evaluating data for reports.
• Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
• Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
• Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
• Responsible for report production processes through finalization, including archival of data as appropriate.
• Assists SD/PI in monitoring study progress.
• Schedules study phases in coordination with SD/PI and lab operations.
• Perform quality control review of data.
• With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
• Provides input and participates in project meetings, plans, monitors and guides project work.
• Trains, mentors, and assists less experienced staff.
• Participates in client visits as needed, assists in communicating technical information.
• Participates in process improvement initiatives.
• Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
• Assists in writing reports and protocols.
• Writes SOPs and methods.
• Maintains an awareness of the financial status of ongoing studies
• Serve as the primary contact in communication and interaction with other departments and clients as applicable.
• Serves as a backup PI/SD on project management tasks.
• Performs other related duties as assigned.

• Minimum Bachelor of Science/Arts (BS/BA) degree with 2-4 years working experience
• At least two years related or relevant experience.
• Experience may be substituted for education.
• Efficient use of word processing software, database, spreadsheet and specialized software
• Proficient in concise writing. Writing should require little or no external review or edit.
• Adherence to grammar, punctuation, composition and spelling accordingly to company standard conventions.
• Experience on a variety of studies performed in the department and exposure to a diverse client base.
• Knowledge of regulatory agency guidance.
• Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
• Proven ability to manage increasingly complex projects and study designs and/or increased study load.
• Demonstrated capability to manage work for key clients.
• Demonstrated ability to support and be involved in process improvement initiates and endeavors
• Proven ability to plan, prioritize and manage workload and multiple responsibilities.
• Demonstrated ability to independently use project tracking systems as appropriate.
• Excellent communication, presentation and interpersonal skill.
• Excellent attention to detail
• Efficient in prioritizing and managing time.