Associate Executive, Regulatory Affairs

HERE YOU ARE. Another day at the office. Time to go home. Remember how proud you were when you landed that great job in that illustrious organization. And now? Well, your work's ok, your colleagues are pretty nice and the office parties get pleasantly out of hands at times. Of course you're keeping your eyes open. You're still very ambitious. You have untapped talent and energy waiting to soar. You want a change. You want new challenges. A new organization. So if you fit the description below, then don’t miss this chance of a lifetime and open your doors to a rewarding career with us.

YOUR RESPONSIBILITIES :

• Assist in product registration including review and preparation of dossier submission.
• Review of artwork labeling based on product category and their regulatory compliance's requirements.
• Serve a supporting role in preparing submissions of various Regulatory applications, variations, and change notifications to the relevant authority(s).
• Ensure timely submissions of product renewals and license renewals.
• Monitor and supervise the status of all Company products’ registration and Company Licenses.
• To check regularly on new regulatory requirements in relevant authority websites (i.e. Directives, circular) and update the team.
• Ensure proper documentation of regulatory and quality activities including SOP preparation and revision.
• Prepare and coordinate with account department to ensure payments are made for various regulatory applications.
• Identifies, evaluates and recommends regulatory strategies in accordance with the company’s objectives.
• Reviews and ensures accurate completion and timely submission of governmental, company and other reports as required in respect of assigned areas of responsibilities.

WHAT WE ARE LOOKING FOR ?

• Possess a Bachelor's Degree in Pharmacy or its equivalent.
• Fresh graduate ais encouraged to apply.
• At least 1 year of product registration experience preferably in the pharmaceutical line or related business.
• Possess analytical skills for interpretation of data and statistics.
• Possess time management skills.
• Must be meticulous with a keen eye for details.
• Proficiency in local languages.

Working Hours : Monday - Friday & Alternate Saturday.

Note: Only shortlisted candidate will be contacted for interview.