Job Description

The Regulatory Affairs Manager/Senior Regulatory Affairs Manager is required to support the business primarily in Singapore by leading and driving new registration filings and line extensions, maintaining product life cycle, managing regulatory activities for labelling updates for the products in the defined therapeutic areas in GSK. And provide regulatory guidance and coaching to the junior team members.The Manager is also required to manage relevant regulatory initiatives and processes in line with local and corporate requirements and be leading regulatory projects and initiatives. And to provide regulatory advice to support the commercial activities including product launches and promotional materials review.Key ResponsibilitiesPlan, strategize and monitor regulatory filings leading to timely submissions and approvals of new product registrations, line extensions and variation applications, clinical trial applications.Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals.Respond to regulatory questions in a timely manner and following consultation with relevant stakeholders. Manage product life cycle maintenance e.g., changes in source, formulation, shelf life etc to ensure no impact to supply due to regulatory reason.Plan and submit labelling updates in line with central requirements and support pack changes and artwork development process to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label.Build effective working relationships with the regulatory agency i.e., HSA and follow up closely on approvals of product registration and variations.Work with all appropriate local functions to develop and implement the best regulatory plans to support commercial goals and product launch excellence.Ensure compliance with local, regional, and Corporate regulatory SOPs and processes. Obtain all relevant licenses and import and export permits in compliance with regulatory requirements.Provide regulatory input to support promotional materials and activities in accordance with local regulatory and internal requirements.Lead regulatory projects and initiatives. Provide regulatory advice and coaching to junior team members and to build team capability.Support QMS and quality compliance activities including provision of regulatory input to the TTS, local repacking, change control, release of first shipment of new product to ensure compliance with the local registered details. Provide regulatory support to product incidents, recalls and audit activities where applicable.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Science-based degree (Pharmacy). Local registered pharmacist.About 8 years\xe2\x80\x99 local regulatory experience in pharmaceuticals MNC for Senior Regulatory Affairs Manager and 6 years for Regulatory Affairs Manager\xe2\x80\x99s role.Strong knowledge of current regulatory requirements.Strong stakeholder engagement skills important for cross functional collaborations.Strong ability to apply scientific and regulatory knowledge.Demonstrated ability to manage relationships with decision makers and key stakeholders, and ability to proactively contribute to cross-functional team.Ability to demonstrate independence and is self-motivated in being a change agent.Professional written and verbal communication skills.Preferred Qualifications:If you have the following characteristics, it would be a plus:Teamwork/collaboration and people management skills.Judgment/problem assessment and problem-solving skills.Building business partnerships.Customer service orientation.Planning and organization/work management skills.Good time management skills, with ability to multi-task and work under pressure.Works with a spirit of continuous improvement and innovation.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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\xe2\x80\x99s 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 \xe2\x80\x93 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.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