GSK

Director, CMC Regulatory Affairs

Employer
GSK
Location
Research Triangle Park, North Carolina; Collegeville, Pennsylvania
Salary
Competitive
Posted
May 11 2021
Ref
289457
Organization Type
Pharma
We're seeking a highly motivated and enthusiastic CMC Regulatory Affairs professional to join the Development Projects (Small Molecules) team in support of the dynamic ViiV Healthcare portfolio.

We will be accepting applications until May 28, 2021.

This role requires you to interact across a wide range of stakeholder functions within GSK including Global Regulatory Affairs, Product Development (PDS), Pharma Supply Chain (PSC) and with relevant stakeholder groups within the ViiV Healthcare organization including Regulatory Affairs, Clinical, Quality, and Supply Chain 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 as well as ViiV Healthcare's commitment to Leave No Person Living with HIV Behind.

This role can be based at our sites in RTP, North Carolina, Upper Providence, Pennsylvania, or Mississauga, Canada and 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.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree or equivalent in pharmacy, chemistry or a related scientific discipline.
  • 7+ years of Chemistry, Manufacturing and Controls (CMC) regulatory affairs experience supporting development of small molecule NCE assets in a fast-paced environment.
  • Experience with regulatory submission preparation and strategy 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.
  • Experience with complex global CMC regulatory requirements and 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 in Pharmacy, Chemistry, or a related scientific field.
  • Experience leading interactions with US FDA and/or other medicinal product regulatory authorities globally e.g. Health Canada or EMA.
  • Ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
  • Experience 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, and Russia.
  • Experience with recent regulatory submissions for drug-device combinations and sterile injectable products.
  • Ability to innovate solutions to complex problems and drive continuous improvement initiatives.
  • Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.
  • Experience leading business critical initiatives and partnering with internal and external stakeholders.


Why GSK?

Our values and expectations are 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
  • Managing individual and team performance.
  • 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.
  • Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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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