Associate Executive, Regulatory Affairs

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 2 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.

Note : Only shortlisted candidate will be contacted for interview.

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