Regulatory Affairs and Quality Assurance Manager
2 weeks ago
**Your new company**
With over 50 years of history, our client is a speciality biopharmaceutical group devoted to helping people around the world live better lives. They are a leader in reproductive medicine and speciality areas within gastroenterology and urology.
**Your new role**- Communicate with regulatory authorities as well as overseas counterparts in regard to regulatory affairs matters such as product registrations, changes in existing products and renewals
- Ensures regulatory support throughout product life cycle including labelling and dossier modifications. Cooperates with other departments to collect information needed for recall reporting, including initial and follow-up reports
- Support activities related to product licensee maintenance and resolution of relevant regulatory issues.
- Ensure compliance of local and international market regulatory requirements (HSA, TGA, FDA, EU, others as applicable)
- Provide QA oversight of activities by partners
**What you'll need to succeed**
- At least 4 years of relevant regulatory affairs experience in Pharmaceuticals industry
- Min. Bachelor’s degree holder in Pharmacy & a Registered Pharmacist in Singapore
- Relevant experiences in regulatory affairs or a similar role/function
**What you'll get in return**
In return, you'll be part of an organization who values their employees. You will have a structured career growth and plenty of developmental opportunities. You will also be compensated with attractive remuneration package.
**What you need to do now**
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
EA License number: 07C3924 EA Registration No: R1982472 Company’s Registration number: 200609504D
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