Assistant RA&QA Manager
ABBOTT Laboratories Ltd.
jobsDB ref: JTH300003001248534
CORE JOB RESPONSIBILITIES:
- Keep contact with Thai FDA
Maintain communication and strengthen relationship with appropriate officers of the Thai Food and Drug Administration (FDA)
Keep update all related regulations on product registration, variation, line extension and other laws and regulations and inform all internal customers.
Coordinate multiple projects and activities in accordance with strategic company objectives and annual plans.
Review, analyze and coordinate to get complete registration dossiers for new product submissions, line extensions according to priorities and responses to deficiency letters in order to get registration approval on time.
Ensure all relevant variations on product registration are in compliance with annual plans.
Provide COA translation to logistic and supply chain department.
Ensure all over labeling activities on imported products are performed for legal allowance of the local sale.
Ensure compliance to applicable local regulations, local requirements and country specific filings.
Ensure labeling is consistent with Company Core Data Sheet (CCDS) and compliant with local requirements as appropriate.
Review and approve printed materials per local label change control procedures.
4.Support to marketing activities
Update registration status on monthly basis to marketing and sale teams.
Provide regulatory input and support for marketing plans, product launches and other cross functional activities.
Review and approve promotional materials before FDA submission or printing release.
Get promotional materials approval by TFDA & MFDA within timeline without major rejection.
Provide regulatory knowledge to marketing team to facilitate tendering, enlisting and bidding activities.
5.Local SOPs and policies
Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs and policies and Thai FDA requirements.
6.Quality Assurance (QA)
Ensure Quality systems are in place and meet requirements of local authority and Abbott standards for commercial affiliate.
Prepare and maintain local SOPs and policies relevant to Quality Assurance to comply with Abbott global SOPs and policies and Thai FDA requirements.
Identify and communicate significant events to site or product quality.
Report all non-medical/medical QA related complaints to finishing/manufacturing site for investigation and respond to complainant and closes out complaint for local market, when applicable.
Monitor and audit the printing supplier, warehouse and distributor to ensure that their activities are compliant with local authority requirements and Abbott standards.
Ensure Pharma over labels and postponement labels are developed, processed and approved in accordance with Corporate Label Change Control and local Pharma label change control procedures.
Perform QA audit to all related TPM and DKSH at Myanmar including CAPA plan acceptance approval.
- Maintain all QA activities to align with internal compliance and international guideline.
- Bachelor in Pharmacy or related fields
- Minimum 5 years of relevant experience
- Excellent spoken and written of English and local language
- Understand of regulatory affairs in medical device / pharmaceutical environment
- Medical sales and clinical experience is a plus.
- Experience in regulatory affairs, QMS, compliance and/or clinical investigations knowledge of regulations applicable to the business
- Experience gained in multinational medical device companies will be an advantage.
- Excellent understanding of the relationship of commercial ops to regulatory/compliance
- Capable of taking Competent Authority relationships to the next level
- High level of responsiveness to need of commercial organization
- Good judgment, ability to prioritize and resource regulatory activity according to business needs
- Ability to work in international environment and willingness to travel
If you aspire to play a role in helping people live healthier lives, join Abbott today. Please click Apply now
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About ABBOTT Laboratories Ltd.
From prevention and diagnosis, to treatment and cure, Abbott is a broad-based health care company that discovers, manufactures and markets innovative products. Abbott is committed to bringing together individuals with diverse backgrounds and interests, and investing in their success. That’s why Abbott ranks among the 2009 ‘100 Best Places to Work’ by Working Mother Magazine and was named in the top 10 of the ‘50 Best Places for Diversity’ by DiversityInc. Magazine.