Regulatory Manager Delivery Lead GRA Vaccine CMC Mature Products
Regulatory Manager Delivery Lead GRA Vaccine CMC Mature Products
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Job Description
At GSK were constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more feel better and live longer. Ensuring all changes for Finished Product and Drug Substance are properly registered and up to date is essential and thats where our CMC Delivery teams experience and support are crucial.
The Team is a part of Regulatory Affairs GSK Vaccines portfolio for registered products ensuring that the CMC information relating to the quality safety and efficacy of our products is correct. This is done through the creation and management of CMC Variation regulatory dossiers which contains information related to the Quality Module of Finished Product and Drug Substance.
In the Regulatory Manager role you have an opportunity to make a real positive impact on GSK Patients worldwide delivering CMC Variations dossiers created by your Team and ensuring continuity of supply for health and life saving medicines.
The Regulatory Manager reports to Director Vaccine CMC Mature Products and is accountable for leading and managing the team responsible for delivering CMC Variation dossiers for US European and ROW markets in line with existing business needs strategies goals and objectives in order to support GSKs product licenses worldwide. Regulatory Manager cooperates with internal and external stakeholders according to agreed ways of working priorities and deadlines to ensure delivery of overall departmental goals.
Regulatory Manager Delivery Lead
In your new role you will:
Manage people aspects of a team of direct reports to create and sustain an efficient qualified and motivating working environment.
Efficiently plan and ensure timely delivery and high quality of Pharma Biopharm and Vaccines CMC projects.
Ensure high standard of submissions and act as quality control point.
Identify risks to quality and/or timely completion of project resolving any issues and escalating items to be resolved at a higher management level.
Drive continuous process improvement within areas of your influence.
Build and maintain quality relations with your internal and external stakeholders.
Work closely with your peers and manager to drive standardization across the business.
Take accountability for tracking analyzing and reporting of team performance against departmental KPIs.
Basic qualifications:
Bachelors degree in scientific or technical field.
Chemistry Manufacturing and Controls (CMC) regulatory affairs orproduct development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these particularly for marketed products capability to build motivate and maintain a team.
Fluent English and Polish (both spoken and written).
Strong interpersonal and communication skills.
Decision making.
Ability to perform multiple tasks set the right priorities to deliver objectives on time.
Adapting to changing circumstances through priorities reassessment and a disciplined logical work style.
Exceptional flexibility and growth mindset.
Preferred qualifications:
Masters degree in scientific or technical field.
Welldeveloped leadership skills.
Change management and strong learning agility.
Negotiation and problemsolving skills.
Practical knowledge of risk management.
Project Management experience would be an asset.
Benefits:
Career at one of the leading global healthcare companies.
Attractive reward package (competitive salary annual bonus & awards for outstanding performance recognition awards for additional achievements and engagement holiday benefit.
Possibilities of development within the role and companys structure.
Life insurance and pension plan.
Open and inclusive environment which is supportive and welcoming of all diversity strands (gender race ethnicity sexuality disability or any other characteristic).
Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
Sports cards (Multisport).
Personalized learning approach (mentoring online trainings platforms: Pluralsight Business Skills Harvard Manage Mentor Skillsoft and external trainings).
Extensive support of work life balance (flexible working solutions including working from home possibilities health & wellbeing activities).
Supportive community and integration events.
Modern office with creative rooms fresh fruits everyday.
Free car and bike parking locker rooms and showers.
Inclusion at GSK:
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Teamto further discuss this today.
#LIGSK #LIHybrid
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is 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. 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 its 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.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
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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 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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Manager
Employment Type
Full-Time
Key Skills
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