Regulatory Project Manager

We are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group.

Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Global Supply Chain (GSC), Technical and Quality representatives and Local Operating Companies to enable an uninterrupted supply of our medicines to patients.

Our work spans all formulation types and markets for marketed small molecules.

We currently have an excellent opportunity to work on exciting projects as well as influence and shape new ways of working.

As Regulatory Project Manager (CMC), you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets.

This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries.

Key responsibilities include maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Matrix Teams.

In delivering your objectives you will partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation), and lead authoring of the variation dossiers and responses to Regulatory Agency questions.

Key Responsibilities include, but are not limited to :

• Developing CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products
• Ensuring all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.
• Ensuring information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply / Production / Quality flexibility with minimal unanticipated questions.
• Working in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
• Maintaining high quality standards, seeking to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions.

About You :

This role involves the development of regulatory strategy and implementation of changes to global processes across multiple locations and stakeholders from the manufacturing business-units.

The role would suit a driven and motivated individual who has experience of working in a complex Regulatory environment.

You will have excellent people skills and be able to work across boundaries, responding readily to changing events and priorities.

You will need to be open-minded, with excellent communication skills and have proven experience dealing with diverse stakeholder groups.

You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise.

Why You?

Basic Qualifications :

• Bachelor's degree or equivalent within a relevant subject such as pharmacy, chemistry, or a related scientific discipline.
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience.
• Direct involvement in regulatory submission preparation in late phase development and / or marketed product life cycle submissions.
• Experience with drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Experience with worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.

Preferred Qualificaitions :

• Masters degree within a relevant subject such as pharmacy, chemistry, or a related scientific discipline
• Regulatory Affairs Certification (RAPS)
• Continued professional growth in global regulatory affairs including communication of evolving / emerging trends and policies.

Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.

• Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
• Strong interpersonal, presentation and communication skills
• May be identified as CMC Regulatory expert in a specific subject area.
• Proactively seeks out and recommends process improvements
• Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project / product strategy.
• Demonstrated ability to handle global CMC issues through continuous change and improvement
• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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, 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.

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