Job Details:
Role Description
The Professional Affairs Specialist, Singapore, MD&D is a member of the local Professional Affairs department, responsible for actively contributing to the regulatory compliance of medical devices and pharmaceutical products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications.
The Professional Affairs Specialist also has responsibilities for maintaining and executing activities in accordance with the Quality Management System, and for oversight of clinical trials within the country.
This position reports to the Singapore Professional Affairs Manager.
JOB RESPONSIBILITIES:
Regulatory Affairs
1.
A member of the local regulatory affairs department within Johnson & Johnson Medical, Singapore, with responsibility for regulatory aspects of the assigned product portfolio/s
2.
Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
3.
Maintain departmental and source company databases of regulatory approvals
4.
Complete copy and labeling review as required
5.
Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Singapore and request the documentation required for registration submissions
6.
Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
7.
Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
8.
Contribute to continuous review and improvement of processes within the Singapore Professional Affairs (PA) department to ensure consistent, efficient and effective practices across the team
9.
Participate in discussion groups for the industry association, as required
10.
Contribute to PA Team meetings to learn from colleagues, share experiences and best practice
11.
Assist PA colleagues in supporting other product portfolios or PA activities, as required
12.
Take responsibility for coordinating the release for supply of unapproved medical devices under the Special Access Scheme (SAS)
13.
Establish meetings with marketing colleagues to share information about new products, line extensions and changes to currently approved products and review timelines for product approvals.
Clinical Affairs
1.
Oversight of local clinical trials and investigator initiated studies, with responsibilities including local safety reporting and complaints handling to the local Health Authority and operating companies, maintenance of Trial Master Files, budget planning and management, site management, regular trial status reporting to the regional clinical trial database, local review and approval of applications for investigator initiated studies, country representation at the regional clinical team meetings, and CRO management as applicable, with supervision from the Medical Director, and guidance from senior clinical colleagues as necessary.
Qualifications
REQUIREMENTS:
- Bachelor's degree or equivalent in Pharmacy or related discipline;
Registered Pharmacist with the Singapore Pharmacy Board is compulsory.
Familiarity with the regulatory systems and product registration requirements in Singapore....
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