Regulatory Affairs ExecutiveAssociate
Job Summary
Business Introduction
At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.
Position Summary
You will support and deliver regulatory activities that help ensure product availability and compliance in Hong Kong and Macau. You will work with global submission teams local regulatory contacts technical operations and commercial partners. We value people who are organised curious and collaborative. This role offers visible impact for patients clear ownership and strong opportunities to grow your regulatory career while uniting science technology and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Support regulatory team for submission preparations of regulatory dossiers and lifecycle maintenance documents for Hong Kong and Macau.
Maintain submission documentations and system compliance for audit readiness.
Manage artwork activities ensuring compliance with systems and processes.
Provide project support to deliver assigned business objectives.
Work closely with internal departments on product lifecycle maintenance to ensure regulatory compliance and supply continuity.
Why You
Work arrangement
This role is on-site in Hong Kong. You will work regularly from the office to collaborate with local colleagues and partners.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelors degree in pharmacy life sciences chemistry or a related discipline.
1-2 years working experience within the pharmaceutical or healthcare industry.
Knowledge of Hong Kong and Macau regulatory requirements and practices is an advantage.
Strong written and verbal communication skills in English; Cantonese or Mandarin is an advantage.
Good organisational skills with attention to detail and ability to manage competing priorities.
Preferred Qualification
If you have the following characteristics it would be a plus:
Masters degree or professional qualification in a related discipline.
Experience working in a matrix environment with global and local stakeholders.
Candidates with relevant experience may also be considered for more senior roles.
What we value in you
You make evidence-based decisions and raise issues early. You balance pace with rigour and focus on quality. You build strong working relationships and share learning. You bring a growth mindset and a willingness to coach others. You will help improve patient access through regulatory excellence.
Ready to apply
If this role feels like the next step for you please apply. We welcome applicants from all backgrounds and support inclusion. Tell us how you want to grow and how your skills will move important regulatory work forward. If you need adjustments during recruitment please let us know and we will support you.
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 were 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 . 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 GSKs 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 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.
Required Experience:
IC
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.