Are you looking to lead CMC regulatory activities in the post approval space for Biopharm products?
As a Regulatory Project Manager, you Will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Lead the regulatory process redesign using lean and six sigma methodologies with cross-functional teams resulting in improved process efficiency and quality.
- Work directly with customers to establish goals and objectives related to lean, process design, including quality targets.
- Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements.
- Prioritize projects to ensure internal resources are appropriately applied to achieve established goals.
- Establish and monitor metrics relative to process redesigns and implementation.
- Conduct periodic progress reviews and update senior leadership on the changes and planned deployment.
- Audit closed projects to ensure results are maintained.
Why you? Basic Qualifications:
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
- Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Works 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.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and sharesbest-practices and learnings within the CMC Regulatory teamsand other impacted functions.
- Engages inCMCSubject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
- Will sometimes deliver CMC regulatory strategy to support major inspections (egPAIs) with managerial support.
B.Sc. in Life Sciences or related scientific disciplines - To ensure a good understanding of the science behind physical product manufacture, and the associated regulatory challenges with maintaining a compliant supply chain.
- 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.
- Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
- 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.
Masters degree in Life Sciences or related scientific disciplines
- 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 with established internal networks.
- 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 andimprovement
- Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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