Regulatory Affairs Specialist at GSK

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

29 Mar, 26

Salary

0.0

Posted On

29 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Product Registration, Life Cycle Management, New Chemical Entity, Line Extension, Labeling Update, Regulatory Submissions, Stakeholder Communication, Regulatory Agency Guidelines, Safety Issues Handling, Impact Analysis, English Communication, Collaboration, Registration Planning, Regulatory Update, Strategic Planning

Industry

Pharmaceutical Manufacturing

Description

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 3+ years 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. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.

Responsibilities

The Regulatory Affairs Specialist is responsible for product registration and life cycle management, including planning and executing regulatory strategies for new products and existing product updates. They will maintain relationships with regulatory authorities and manage regulatory issues effectively.