Building a dynamic and motivated team is paramount to achieving our goals. To meet our growing business needs, we are seeking dedicated, motivated and result-oriented candidates to join us. Come and meet up with us for a discussion on how you may be suitable for these roles:
Regulatory Affairs Specialist (Medical)
The Regulatory Affairs Specialist is responsible for assisting our senior RA/Ops manager in ensuring overall compliance to regulatory framework governing the registration, distribution and post market surveillance of our products.
- Hands-on compilation and submission of technical documents, change notification and licence renewals of new and existing product portfolio
- Pro-actively liaise with HSA to communicate and overcome challenges in product registration and change notifications
- Collaborate with overseas partners for submissions. Prioritise and manage timelines to ensure timely market launch of pipeline products
- Assist operation team to monitor compliance of marketed products to approved attributes and local requirements
- Review labelling/marketing materials for regulatory compliance
- Monitor and report ADR/FSCA/Recall to regulatory authorities when necessary
- Provide Pharmacovigilance Process training
- Develop and maintain regulatory intelligence of SEA regulations
- Other work that may be assigned by manager
- Bachelor’s Degree in Pharmacy or in Science/Biomedical fields
- 1-3 years of working experience with knowledge of current regulatory requirements: European Medical Device Directive/ ISO 1348; ICH Guidelines/Dossier requirements, GDPMDS and GDP (Pharma) requirements
- Experience in compilation and submission of Common Technical Dossiers (Medical Device-CSDT and Pharmaceutical-ACTD/ICH CTD)
- Experience in liaising directly with premarket/post-market branches in HSA
- Possesses excellent communication and interpersonal skills
- Possesses good organizational and communication skills, positive mindset and is results oriented
- Meticulous, self-disciplined and enjoys challenges
- Fluency in spoken and written English is essential
Interested candidates please email detailed resume and expected remuneration to: HR-Admin ; Closing date: 23 November 2020. We regret only shortlisted candidates will be notified.
By submitting any application or resume to us, you will be deemed to have agreed & consented to us collecting, using, retaining & disclosing your personal information to HR/Hiring managers in Novem Group of Companies for reviewing your suitability for this role or other suitable positions.