Position purpose:

Submission Management Team is expected as one innovated business process into regulatory affairs. The critical outcome is to develop and plan the regulatory submission strategy and implement the submission strategy to deliver agreed registration milestones with the high standard of regulatory submission dossier and efficient manner. Interacts with Regulatory Authorities to maintain awareness of current regulations related to submissions for medicines. Manager is responsible for overall process of submission dossier preparation and submission for all life cycle activities.

Key Accountabilities/Responsibilities

• Creates and manages the submission strategy & dossiers preparation plan.
• Responsible for module 1 documents preparation, such as certificate documents, INN, trade name, patent, etc. Responsible for dossier format.
• Provides timely and high-quality regulatory submission support on nonclinical part.
• Ensures timely submission delivery to HA for all life cycle activities, including IND, NDA, post-approval changes, renewal, annual report, etc.
• Responsible for dossier archiving, ensure that regulatory information management system is updated, and registration documents are archived timely.
• Responsible for labelling (e.g. carton, inner label) and artwork execution.
• Continually monitors, interprets and validates current and evolving Health Authorities submission regulations and assesses the potential impact to submission processes to ensure compliance and efficiency in the delivery of submissions.
• With support from line manager, this position contributes to solutions to regulatory submission issues by ensuring potential risks are identified and mitigation plans are put in place. This position also contributes to continual process improvement and change management procedures.
• Ensures regulatory submission activities compliant with company internal and local policies.
• Guides junior submission colleagues to implement the submission strategy & dossiers preparation plan; conduct cross-functional meetings related to submissions.
• With support of line manager, take ownership and leadership of some assigned tasks besides product projects.
• Supports other tasks assigned by line manager, such as ad-hoc tasks, contribute comments to Taskforce.

Qualification:

• Bachelor or above degree in a Life Science related discipline
• Strong written and oral communication skills in English and Chinese
• At least 5 years experience in the pharmaceutical industry, preferably in drug development or regulatory affairs, and at least 3 years in MNC.
• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines (eg, NMPA, CDE, ICH, FDA, EMA, etc).
• Project management skills strongly desired.
• Capability to foresee potential risks and issues solving in complicated situation.
• Ability to handle time pressure and the consequence of any delay in timely submissions.
• Good ownership and leadership of projects.
• Good communication skills and good ability of cross-team co-operation.
• Can work independently, ability to multitask, self-motivated, well organized and adaptable, detail-oriented, able to prioritize and work well with others.
• Affinity to work with complex IT systems. Strong knowledge with MS Office applications and Adobe Acrobat is required.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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