OVERALL PURPOSE OF JOB

• Products Registration and the life cycle management of existing products (CMC variation, labeling update and maintenance of the product licenses) with timeline set-up.

• Short & Long term registration planning for NCE, LE and new indications including bridging strategy

• Management of other regulatory issues

ACCOUNTABILITIES & RESPONSIBILITIES

• Planning the best case scenarios of RA plans for NCEs, Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Meeting.

• Establishment of short & long term detailed registration plan and follow up to meet the expected approval timeline

• Maintenance of good relationship with regulatory authority and internal stakeholders.

• Timely and appropriate regulatory update of existing products (shelf life extension, CMC variation, site transfer, GDS update and renewal etc.)

• Management of the existing products (safety issues handling, 3rd party support, TTS update, Registration of Drug ID Mark etc.)

• Communication and cooperation with GRA for regulatory requirements.

• Impact analysis and establishment of strategy according to the amendment of the guidelines

REQUIREMENTS

• Minimum 3+ years (7+ years for Senior RA specialist) of experience in regulatory including the leadership and delivery of a range of regulatory submissions

• Bachelor’s degree in Pharmacy, Biological, Chemical or life-science related

• Knowledge of regulatory agency guidelines and expectations in the submission process

• Experience in the regulatory agency review process

• Proficient English communication to effectively communicate with global and regional colleagues

• Preferred if candidate has experience on Vaccines related

*LI-GSK

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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