Regulatory Affairs Executive/Manager (2 years contract)

Singapore
Permanent
Full-time

1 day ago

As a Regulatory Affairs Executive/Manager, you will play a pivotal role in supporting the business by driving regulatory activities, ensuring compliance, and enabling timely submissions and approvals for product registrations and life cycle management within the defined therapeutic areas. Your expertise will provide regulatory guidance to support product launches, promotional materials, and overall commercial strategies.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…Key ResponsibilitiesPlan, strategize, and monitor regulatory filings to ensure timely submissions and approvals of new product registrations, line extensions, variation applications, and clinical trial applications.Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals.Respond to regulatory questions promptly following consultation with relevant stakeholders.Manage product life cycle maintenance, such as changes in source, formulation, or shelf life, to ensure no impact on supply due to regulatory reasons.Plan and submit labelling updates in accordance with central requirements, and support pack changes and artwork development processes to ensure compliance with local registered details and corporate prescribing information, while maximizing the commercial value of the label.Build effective working relationships with the regulatory agency (e.g., HSA) and follow up closely on approvals for product registrations and variations.Collaborate with all appropriate local functions to develop and implement the best regulatory plans that support commercial goals and product launch excellence.Ensure compliance with local, regional, and corporate regulatory SOPs and processes. Obtain all relevant licenses and import/export permits in compliance with regulatory requirements.Provide regulatory input to support promotional materials and activities in accordance with local regulatory and internal requirements.Support QMS and quality compliance activities, including providing regulatory input to the TTS, local repacking, change control, and release of the first shipment of new products to ensure compliance with local registered details. Provide regulatory support for product incidents, recalls, and audit activities as applicable.Why you?Basic Qualifications:We are looking for professionals with the following required skills to achieve our goals:Bachelor’s degree in pharmacy or a science-based discipline (Pharmacy preferred).Knowledge of pharmaceuticals, including pharmacology and technical processes such as manufacturing and quality control, gained through academic and professional experience.Proven regulatory affairs experience in pharmaceuticals.Preferred Qualifications:If you have the following characteristics, it would be a plus:Strong teamwork and interpersonal skills.Effective time management skills, with the ability to prioritize, multitask, and perform under pressure.A proactive approach to continuous improvement and innovation.Why GSK?Our values and expectations are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.

*This is a job description to aide in the job posting but does not include all job evaluation details.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.Important notice to Employment businesses/ AgenciesGSK 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.

GlaxoSmithKline

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