You will be responsible for:
- Ensure all products marketed are compiled with local regulatory requirements.
- All products submitted for product registration are done in a timely manner and with the most cost efficient manner.
- Maintain the registration action plan and budget plan, be responsible for the registration timeline of the team.
- Close monitoring the quality for submission dossier of the team. Keep records. Make sure all team member(s) have clear filing and maintain of all documents per SOP requirements.
- Close work together with clinical operation team, provide the regulatory opinion on time.
- Maintain a good working relationship with the local Authority.
- Maintain an up to date database on status of all products marketed.
- Manage a team of staff and co-ordinate all activities in tandem with marketing activities.
- Interface with Global Regulatory Department for updated information for product registration.
- Lead a team and work with sales and marketing dep. Set up the registration plan and budget plan, to fulfill product registration plan for certain product line. Achieve RD expectation on product registration with the compliance local regulations manner.
- Lead the team to make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, share points, V drive per company SOP requirements.
- As a member of RD, provide active and strong regulatory supports to internal dep. as needed.
- Lead the team, active involved in the national standard or panel verification or national/industrial standard discussion and verification.
- Manage and approve the FOC for the registration purpose, manage the Demo instrument that for the registration purpose.
- Close collaborate with clinical operation team, provide the regulatory opinion to the protocol and CSR of the clinical study or clinical evaluation for the registration purpose.
- Other projects or tasks assigned by line manager.
- Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
- Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).
You should have:
- Bachelor degree or above, subject on medicine/biology/bioengineering/clinical medicine or biochemistry.
- Familiar with medical device regulation.
- Fluent English in listening, speaking, reading and writing
- Good skill on computer, MS-Office operation.
- At least 10 years of working experience in either a Pharmaceutical or Diagnostics industry
Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs