Regulatory Affairs Specialist (Medical/ Therapeutic Products)
Location: Pasir Panjang
Salary: Up to $6500 depending on experience
Our client, a MNC company in BioPharmaceutical Industry is currently looking for Regulatory Specialist to join the team .
- Responsible for management of integration projects.
- Plan and prepare regulatory submissions of therapeutic products and medical devices.
- Support lifecycle management activities and ensure regulatory compliance is maintained.
- Manage integration projects for Singapore and Philippines.
- Review all current approved labels to ensure the content is in accordance with local regulatory requirements, local regulatory approved documents and reference documents.
- Identify label deviations and collaborate with cross functional stakeholders to determine the remediation plan.
- Plan for notification and submission to the Regulatory Authority, where applicable.
- Manage marketing authorization transfer activities for therapeutic products and medical devices.
- Monitor the progress and provide updates on project status during meetings.
- Manage labeling changes, artwork development and artwork approval of packaging material components.
- Update and maintain regulatory databases.
- Keep up to date for law & regulations knowledge related to integration projects.
- Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution,sale & marketing of AbbVie products and related to integration projects.
- Facilitate communication between cross functional stakeholders, Area Regulatory lead, local
- regulatory authority and local distributor.
- Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
- Monitor progress of variations approval process within Regulatory Authority.
- Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
- Manage labeling changes, artwork development and artwork approval of packaging material components
- Update and maintain regulatory databases
- Bachelor's Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies
- Minimum 2 years experiences in regulatory function in a pharmaceutical and medical device
- Understands business needs and impact of regulatory issues
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579