SENIOR REGULATORY AFFAIRS SPECIALIST (PHARMACEUTICAL)
PRTR Recruitment and Outsourcing Thailand
jobsDB ref: JTH300003001238482
Employer Ref. 114DB
Our client isa leading global pharmaceutical products company.They are currently seeking dynamic and qualified candidates to work in the position ofSenior Regulatory Affairs Specialist to support their growing business.
Salary: 55,000-75,000 Baht/month
- Compiling and submitting registration dossiers to local authority to obtain regulatory approvals in a timely manner.
- Maintaining product licenses by ensuring that all renewals, variations and label updates are submitted and approved within the required timeframe to ensure supply continuity and regulatory compliance.
- Monitoring the regulatory environment and taking proactive actions to notify company of new requirements that may impact submissions to be made.
- Maintaining proper records of regulatory submissions and approvals and updating databases for RA information /documents.
- Reviewing local promotional materials.
- Representing Regulatory Affairs in project teams to provide relevant regulatory advice
- Closing and effectively following up with local regulatory authorities on the company’s submissions.
- Closing and effectively collaborating with cross-functional teams at local and region levels
- Providing support for tender submission.
- Performing and handling QA compliance activities as needed with the support of Regional QA such as local product release and product complaints, and managing relabeling in accordance with applicable local regulatory requirements and internal SOPs
- Being the local contact point for global/regional QA on QA issues
- Handling adverse event reporting and submissions according to internal and external regulatory requirements with the support of global/regional PV.
- Bachelor’s degree or above in pharmacy or other related scientific discipline.
- Minimum 3 years of relevant experience in the pharmaceutical industry.
- Able to work independently.
- Strong knowledge of RA requirements, QA experience is desired.
- Ability to work independently with attention to details.
- Ability to multi-task and work well under pressure.
- Strong oral communication and relationship building skills.
- Fluent in spoken and written English.
Qualified candidates please submit your resumes stating present and expected salary & package details by click "APPLY NOW"
2034/127 Ital-Thai Tower, 18th Floor,
New Petchaburi Road, Bangkapi, Huaykwang, Bangkok 10320
jobsDB will send your application for review directly to PRTR Recruitment and Outsourcing Thailand
About PRTR Recruitment and Outsourcing Thailand
Since PRTR’s establishment in Thailand in 1990, we have been a part of a roller coaster ride called Thailand's economy. We have witnessed the highs of the property boom, the collapse of the currency, the pain Thailand suffered facing up to the stringent demands of the IMF, the demise of the American mortgage market, Thailand’s ongoing political power struggle and the recent devastating floods. We are now playing our part in Thailand's future, which will see a steady annual growth, improved health and welfare services, a decrease in poverty, an increasing domestic demand from a growing middle class and a business environment that dictates transparency and increased honesty.
We currently have 5 offices in Bangkok and 2 offices in the Eastern Seaboard of Thailand employing a total of 232 staff with a further 41 staff supporting our client partners at their locations in Thailand. Our plan is for PRTR to become Thailand’s most successful recruitment, staff outsourcing and business process outsourcing services group of companies.