全职 REGULATORY AFFAIRS OFFICER 工作, 薪水 up to MYR 3,000, ASWAT PHARMACY MANAGEMENT & RETAILS CONSULTANCY SDN BHD Federal Territory 公司招聘中 - Ricebowl

1. Responsible to ensure the project assigned will be completed in due time comprising of below (but not limited to):

• Submission of product registration, product classification, product variation, import/wholesale/manufacturing license application via Quest3+ on behalf of the client.
• Submission of Quest3+ token application on behalf of client.
• Review of dossier provided by the clients and provide feedbacks on the correction required for the dossier.
• Project timeline preparation and regular updates to clients
• Studying scientific and regulatory guidelines.
• Updating knowledge and latest requirements based on new/revised regulatory guidelines and/or requirements.
• Gathering, evaluating, organising, managing and collating information in a variety of formats to ensure dossier completeness.
• Ensuring the dossier compliance with regulations set by the NPRA
• Maintaining familiarity with client’s product ranges
• Liaising and negotiating with regulatory authorities NPRA on any correspondence received for any application submission.
• Writing comprehensible, user-friendly, clear product information leaflets and labels and RiMUP.
• Ensuring that quality standards are met and submissions meet strict deadlines
• Preparation of QMS and QC documents and procedures related to the needs of clients
• Preparation of qualification and validation documents related to the needs of the clients

2. Provide professional advice in pharmaceutical regulatory related matters with regards pharmaceutical product registration, importation, distribution, and manufacturing.

3. To ensure any other task as assigned by the management of the company is being carried out from time to time.

We are looking for candidate as below categories:

· Hardworking and trustworthy

· Willing to travel locally

· Basic knowledge in Quest3+ system

· Minimum in bachelor’s degree or Professional Degree in Science or equivalent.

· Minimum 1- 2 years working experience in any regulatory affairs will be added advantage

· Possess good communication skills, interpersonal skills and customer service skills.

· Must be an objective driven person

· Able to work on long hours and possibly including weekends (if required)

Pay: RM2,600.00 - RM3,000.00 per month

Benefits:

• Cell phone reimbursement
• Flexible schedule
• Free parking
• Maternity leave
• Professional development
• Work from home

Willingness to travel:

• 50% (Preferred)

Work Location: In person