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Director, Small Molecules CMC Regulatory Affairs.

Collegeville, Pennsylvania
Closing date
Oct 11, 2022

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Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director Small Molecules CMC Regulatory Affairs could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives.

Our team holds CMC Regulatory responsibility for a portfolio of new small molecules and oligonucleotide products. In this role, you will have visibility and interface with all technical functions in CMC - including product development, chemical development, analytical sciences, supply chain and other stakeholders - as well as the wider regulatory matrix team. As the CMC Regulatory leader, you will own strategy and oversee management of regulatory tasks which enable success of small molecules CMC. You will support projects from first-in-human, through clinical development and marketing applications, right through to early lifecycle for marketed products. As such, you'll set the strategy for managing CMC regulatory affairs in this space, taking a long-term perspective and big picture approach whenever possible, whilst also ensuring key operational tasks, such as successful completion of submissions.

Given the breadth of visibility you have, your internal partners will consist of a large network within R&D and Pharma Supply Chain and will require you to act as a key interface between both. This role will also offer the opportunity to regularly interact across a wide portfolio and a range of modalities, including Vaccines and Biopharmaceutical products in support of cross-modality initiatives. You'll also maintain current market knowledge through both internal and external advocacy, and will fit into a positive, supportive, and nurturing team which prioritizes development and continuous improvement of both process and people.

You will be a critical partner to several different business areas - in most situations acting as a key input and source of expertise. As such, the job calls for excellent stakeholder engagement and partnership skills including the ability to balance the expectations and attentions of a complex matrix organization.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Delivering key, strategic global CMC regulatory activities as an individual contributor from early phase clinical submissions through to marketing applications, and early lifecycle activities, responding readily to changing project events and priorities.
  • Understanding, interpreting, and advising the technical and development teams on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of new pharmaceutical products.
  • Supporting expedition of submission, review and approval of global CMC applications.
  • Communicating strategic direction, data assessment and risk mitigation strategies to senior management.
  • Maintaining high quality standards, seeking to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

Why You?

Basic Qualifications:
  • Bachelor's degree within a relevant subject such as chemistry, pharmacy, or a related scientific discipline.
  • Minimum 7 years' experience within Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical/pharmaceutical development experience.
  • Minimum 7 years' experience in regulatory submission preparation across all stages of development from First Time in Human through marketing authorization and early post-approval life cycle submissions.
  • Extensive Small molecule (NCE/NME) experience.
  • Experience managing and directing multiple projects and matrix teams.
  • 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
  • Experience of clinical trial processes.
  • Must have experience leading interactions with US FDA and/or other global regulatory authorities.
  • Must have Pharmaceutical and/or biotech industry experience.
  • Significant experience in problem solving and continuous improvement.

Preferred Qualifications and experience:
  • Advanced degree MS or PhD.
  • 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.
  • 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.
  • Some Large molecule experience would be considered a plus.

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.

~We Look Forward To Working With You !~


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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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