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• Bachelor degree in pharmacy, chemistry or related scientific discipline or equivalent qualification.
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply these, particularly for new medicines in development.
• Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
• Excellent team working abilities and effective influencing skills.
• Strong verbal and written communication skills with good attention to detail.
• Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
At GSK, our Development Projects regulatory affairs group is responsible for a portfolio of new, “small molecule” and oligonucleotide products. We are offering a truly global role for a highly motivated regulatory affairs professional responsible for Chemistry, Manufacturing and Controls (CMC) support for new medicines. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patient’s lives.
• Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
• Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities.
• Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
• Work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing.
• Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment.
When applying for this role, please use the 'cover letter' of the on-line application to describe how your experience meets the competencies for this role. In addition, please provide a copy of your current CV. The information that you have provided in both your cover letter and CV will be used to assess your application against the requirements of the described role.
You may apply for this position online by selecting the Apply now button.
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