Job Purpose

• 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 New Chemical Entity(NCE), Line Extension and new indications including bridging strategy

• Management of other regulatory issues

RESPONSIBILITIES

• Planning the best-case scenarios of RA plans for NCEs, Line Extensions and New indications and sharing the RA strategy with stakeholders through New Product Introduction(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, IQA 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 can be suggested after the interview) 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

GSK provides preferential consideration to applicants with disabilities in accordance with the Act on the Promotion of Employment of Persons with Disabilities and Vocational Rehabilitation. We uphold diversity and inclusion as core values, and we are committed to providing equal opportunities to all talents, regardless of disability.

*LI-GSK

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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