CMC Regulatory Manager

Basic qualifications:

  • 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.
  • Detailed knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
  • Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
  • Successfully influenced and negotiated issues at a senior level within your organisation and with regulatory agencies in a variety of settings.
  • Proven ability to manage and direct multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities.

Preferred qualifications:

  • Strong verbal and written communication skills with good attention to detail.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.
  • Experience of being involved in/leading business critical activities within and external to the organisation.

Details:

Job Description:

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.

Key responsibilities:

  • 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 seek to raise levels of performance through continuous improvement and an 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.

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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