Skip to main content

This job has expired

Regulatory Affairs Specialist

Employer
Pharmiweb Partner Job (APAC)
Location
Sydney, Australia
Salary
Competitive
Start date
2 Oct 2022
Closing date
8 Oct 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Position Overview / Purpose: T

his role's primary mission is to accelerate products' approval for Japanese Market by working as project's member. Depends on the person's skill, experience and motivation, the position might lead the project. This primary mission includes to work based on enough knowledge about Japanese regulation including Clinical affairs and Quality management area that should be known by RA person for product submission.

This role also should contribute on increasing compliance level according to Japanese Pharma and Medical device law by helping qualified supervisors and RQR director. This is including expectation to maintain business licenses that NCC has and will have.

This role will might be involved reimbursement project. This role is supposed to have motivation to learn about reimbursement system not only as a RA specialist but also as project member of reimbursement specific matters.

This role will might work with external experts for Pre-approval clinical trial for regulatory purpose or PMS work when new product submission and QMS relevant work will be slightly at that period.

Accountabilities:

Accountability 1: Regulatory Affairs (Yakuji Shonin)
  • Contribute establish and maintain effective project management system of NCC to share RA project relevant information to accelerate product approval.
  • Seek the most reasonable way to prepare dossier and response to PMDA's inquiries while highly compliance level. When the dossier cannot enough data that is required by Japanese authority, risk analysis to submit the dossier without the particular data and convince team member about that plan is strongly required.
  • Submission dossier must be prepared for the latest PMDA's requirements as much as we can know. For potential delay of the submission timing and risk must be analyzed and shared as well as the above item.
  • Keeping record about internal/external discussion and others, and good filing according to NCC RQR rules is required.
  • Flexibility is welcomed as long as the specialist keeping good compliance level to law and regulation.
  • Accuracy of submission dossier is one of key for success.
  • Passion to know technology and medical theory is also key element for success.
  • Regulatory strategy must be suggested to team based on the listed items here.

Accountability 2: Reimbursement and Clinical matters
  • Flexibility and motivation to lean additional required area such as deeper reimbursement work or Clinical work is required. These will be requested to start learning by NCC RQR Director according to NCC's situation and discussion to set personal development goal.

Accountability 3: Quality Management System
  • Enough knowledge about QMS for RA product submission work and QMS inspection and reliability inspection work is minimally required.
  • Support qualified supervisors according to set procedures are required.
  • Motivation to lean about deeper QMS things to establish/improve Quality Management System is required.

Accountability 4: Business license Maintenance
  • Support the maintenance work of license including Foreign Manufacturer Registration. Suggest necessary renewal plan to NCC RQR Director with QA manager.
  • Support business license obtain/renewal project. Work with foreign manufacturers for FMR timely in collaboration with QA manager.

Accountability 5: Others
  • Maintain and develop contacts with regional colleagues, business partners, industry associates, regional regulatory bodies and medical society.
  • Monitoring government legislation relating to PMDL.

Team Role (Individual contributor):
  • This role will be required to provide back-up support to other role in the department as needed.
  • Follow to direction by RQR director or project managers/leaders.
  • Comply existing SOPs and WI and contribute improvement those by communicating with team.
  • Keep seeking reasonable communication with team (NCC RQR, whole NCC, APAC RQR and other Cochlear people)

Key Incumbent requirements:

Minimum:
  • Adhere to the principles of code of conduct as a member and representative of Cochlear group
  • Interpret correctly Japanese regulation and keep maintaining knowledge. Develop, implement and ensure compliance of relevant SOPs
  • Bachelor's Degree
  • 5 years or more of experience in medical device regulatory affairs in Japan (product registration of class III or IV) and its active worker
  • Expert knowledge of Japanese Pharmaceutical and Medical Device Law and the product registration process
  • Business level English of writing and reading and moderate level of speaking
  • High level of Japanese usage to understand legal term and technical terms which is required RA expert.
  • Smooth operation of MS Word, PowerPoint, Excel and Visio (+Photoshop, hopefully)
  • Reasonable communication skill.
  • Motivation to learn new things according to the situation.
  • Overseas travel (0-2/year) and domestic travel (0-10/year)

Ideal:
  • Willingness to manage the long-term project or project by team, and to resolve the complicated situation/subjects.
  • Experience to establish/improvement Quality management system (can be partially).
  • Bachler degree of science (pharmacy, engineering and others)
  • Business level of English speaking

Development Value of this role:
  • Opportunity to learn new area relevant to RA work and expand expertise.
  • Opportunity to work in a multinational Australian owned organization
  • Share in the excitement of bringing new technologies to market

Region-specific Requirements:
  • Native level Japanese proficiency

Advertised: 14 Jul 2022 Tokyo Standard Time

Anticipated Application Closing: 31 Oct 2022 Tokyo Standard Time

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert