Regulatory Affair Executive
Petaling Jaya, Malaysia
Job Description
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Responsibilities:
Follow MKN, KKM SOPs. Application Question(s):
- Responsible for preparation, submission, follow-up with appropriate regulatory / notified bodies on questions / concerns / progress of registration application until license approvals and tracking progress to ensure speedy approval.
- Responsible to provide regulatory expert guidance and reviews in regulatory compliance, assist in developing rationale and documentation of product changes, testing, design reviews, labeling changes, packaging changes, material changes etc.
- Responsible to prioritize, analyze & review registration documents for new product registration, variations, amendments for local according to Company objectives.
- Responsible to develop and design standard procedure for product or device registration application. To have an audit check for every quarter on the regulatory activities.
- Provide management with updates on status of Regulatory filings and proactively notifies management of potential difficulties in meeting timelines and/or quality standards for Regulatory filings. To disseminate regulatory changes to the related Business Unit Manager in the company.
- Maintain complete database of registration requirements, status/expiry dates, renewal deadlines, etc for domestic and regional countries. To maintain product licenses validity and to apply for re-registration when necessary.
- Typing, scanning, photocopying, filing, keeping and maintaining records required for smooth operation of regulatory functions.
- Plan annual regulatory activities and registration budget.
- To assist Designated Person on performing assigned duties and responsibilities from time to time.
- Any other functions and responsibilities as and when required by the superior.
- Open for Malaysian only.
- Candidate must possess at least a Bachelor\'s Degree, Post Graduate Diploma, Professional Degree, Chemistry, Medical Science, Pharmacy/Pharmacology, Biotechnology or equivalent.
- At least 3 year(s) of similar working experience in the Healthcare/Medical industry.
- Preferably Junior Executives with experienced in GDPMD audit / liaise with MDA / NPRA / Sirim and other related authorities.
- Posses own transport and willing to travel.
- Health insurance
- Monday to Friday
- Performance bonus
Follow MKN, KKM SOPs. Application Question(s):
- What is your current/previous salary?
- What is your expected salary?
- How long is your notice period?
- Health insurance
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Job Detail
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Job IdJD919667
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationPetaling Jaya, Malaysia
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EducationNot mentioned