Regional Regulatory CMC Conformance Manager (Japan)/薬事規制（RA）マネジャー（シンガポール所在）

General Summary
Responsible for all tasks associated with managing product lifecycle maintenance and submissions for Japan. The position is responsible for coordinating with the Country Office in Japan to provide and manage the implementation of appropriate submission strategies in support of CMC Change Control to ensure timely and effective submission and approval with Boards of Health.

Principal Duties & Responsibilities
-Provide and implement submission strategies associated with the management of CMC changes, initiated by either the manufacturing sites or Country Office, to ensure timely and effective submissions to the Boards of Health.

- Manage lifecycle submissions for the assigned countries, including but not limited to Market Application amendments, variations, renewals, supplemental submissions.

-Coordinate with the Regulatory Process & Systems Support and Publishing team for the generation of the submission ready components (SRCs) required to support these regulatory submissions.

- Prepare / assemble regulatory dossiers and ensure they are complete, properly formatted, and comply with applicable regulatory requirements prior to providing them to the Country Offices for submission to the BoH.

- Coordinate with relevant stakeholders in providing timely responses to questions raised by Board of Health resulting from regulatory submissions.

- Update and maintain the CMC change management electronic systems to ensure alignment with the regulatory information submitted to and approved by the BoH and/or by the appropriate functional area(s) in the company.

- Support manufacturing sites in PGM network with Board of Health inspections resulting from lifecycle submissions.

- Interface with multiple levels and departments in manufacturing sites, Country Offices, BUs and Divisions to provide guidance, expertise and activity status on assigned products / projects.

- Any other duties as assigned by the supervisor.

About the Company
PharmEng Technology is an international professional service provider and consultancy, headquartered in Canada. We provide professional services to the pharmaceutical, biotechnology, medical device, and other regulated life science companies. The scope of services cover manufacturing compliance, quality assurance, validation, engineering, regulatory affairs, as well as training services. With permanent offices across the US, Canada, Taiwan, and Singapore, our global team of consultants have helped companies in six continents deliver successful projects and compliance.

Welcomed Skills or Experience
For this particular position, we welcome candidates with 3-5 years of direct experience in the relevant tasks. Experience and knowledge in other areas of pharmaceutical manufacturing or development, such as research, development, and quality assurance, are an asset.

Welcomed Personalities
A client-oriented personality, attitude for problem-solving, strong self-motivation and independence are highly desired. This work will require direct interface with the client.

Company Atmosphere
As a professional service firm, our company has a flat organisational structure. You attitute and aptitude will determine your own success as a consultant.

Welfare
Company welfare is provided based on local terms. For example, in Singapore we follow typical welfare practices in Singapore.

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