Regulatory Affairs Specialist II
Thermo Fisher Scientific Jurong West
Job Description
- Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.
- Review and edit dossiers to meet countries requirements, ensuring the accuracy and consistency of information.
- Support SEA countries channel partners in complying strictly with local regulations.
- Collaborate with internal and external partners to address regulatory obstacles.
- Respond to questions related to product registration and change notification from regulatory agencies.
- Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.
- Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.
- Provide input for regulatory change assessments to determine the impact on registrations.
- Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
- Assist in QMS maintenance and internal/external audits.
- Support GMP certificate renewals in countries where applicable.
- Bachelor's degree or equivalent experience in a relevant field.
- 2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.
- Outstanding organizational skills with the ability to manage multiple tasks.
- Strong communication and interpersonal skills.
- Ability to adapt and succeed in a fast-paced environment.
- Dedication to excellence and a high level of integrity.
Bukit Merah, 15 km from Jurong West
I am currently looking for a Junior Regulatory Affairs Specialist for one of my Pharmaceutical client. This is a 3 months contract and will be ideal for any Registered Pharmacists whom are looking to foray into the Pharmaceutical industry.
Role...
Kang Shi Fu Beverage SingaporeJurong East, 4 km from Jurong West
Regulatory Affairs Specialist]
Summary
We are seeking a detail-oriented and results-driven Regulatory Specialist to join our team. You will play a crucial role in ensuring our success by safeguarding product quality and safety through strict...
Private AdvertiserBukit Merah, 15 km from Jurong West
materials, and other relevant documentation
• Provide regulatory guidance and support to internal stakeholders
Requirements:
• Minimum Degree in related courses and above
• Prior 3 years of RA Manager / 6 years of Senior RA Specialist experience...