Director, Global Chemistry Manufacturing and Controls (CMC) Regulatory Affairs, Small Molecule

    • Collegeville, PA

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Sep 21 2020
We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group. At GSK, our Development Projects CMC regulatory affairs group is responsible for a portfolio of new small molecule and oligonucleotide products.

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 patients' lives enabling them to Do More, Feel Better and Live Longer.

This role can be based at our site at Upper Providence, Pennsylvania, USA or Ware, UK sites, however this role will interact across our global network.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • You will direct key, strategic global CMC regulatory activities from early phase clinical submissions through to marketing applications and early lifecycle activities and respond readily to changing events and priorities.
  • You will understand, interpret and advise teams 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.
  • You will communicate strategic direction, data assessment and risk mitigation strategies to senior management.
  • You will 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.
  • You may have direct line management responsibility.

W hy you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • 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 chemical/pharmaceutical development experience
  • Experience with regulatory submission preparation across all stages of development from First Time in Human through marketing authorization and early post-approval life cycle submissions.
  • Experience managing and directing multiple projects/matrix teams simultaneously
  • Small molecule (NCE/NME) experience
  • Detailed knowledge of complex global CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development

Preferred Qualifications:
If you have the following characteristics and experience, it would be a plus:
  • Advanced degree
  • Experience leading interactions with US FDA and/or other global regulatory authorities
  • Ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
  • Track record of successfully influencing and negotiating issues at a senior level within your organization and with regulatory agencies in a variety of settings.
  • Strong verbal and written communication skills with good attention to detail.
  • Experience with clinical trial and marketing application submissions in Emerging Markets, especially China, Brazil, Russia
  • Experience with recent regulatory submissions applying accelerated regulatory pathways (e.g. PRIME/Breakthrough/Sakigake)
  • Experience with recent regulatory submissions for drug-device combinations, sterile injectable products, oligonucleotides, or synthetic peptides.
  • Direct line management responsibility
  • 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 initiatives within and external to the organization.

Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

LI-GSK

LI-GSK

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