Director, Global Regulatory Affairs Lead

We have exciting career opportunities in Global Regulatory Affairs for senior level individual strategic contributors to support exciting and innovative research across a variety of specialty therapeutic areas and potentially including Covid-19 therapies. Since the COVID 19 outbreak, we have been actively exploring ways to help, with our science and expertise, alongside protecting the health and wellbeing of our people and managing our global supply chains to support patients and consumers who depend on our products. This represents an exciting opportunity to be part of GlaxoSmithKline (GSK) Pharmaceutical Research & Development (R&D), who is committed to innovative scientific research and discovery to help people do more, feel better, live longer.

Ideally, the role will be located in Collegeville, PA but remote working arrangements may be considered on an individual basis for candidates not local to our Collegeville campus.

In this role, you will provide regulatory strategic leadership and support for early and/or late-stage Pharmaceutical R&D portfolio

Therapeutic Group, Global Regulatory Affairs

Our Global Regulatory Affairs (GRA) Therapeutic Group (part of the Global Regulatory and Quality organisation in Pharmaceutical R&D) develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with Pharmaceutical R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK.

We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders. We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders

The Role - Director, Therapeutic Group, Global Regulatory Affairs

The Director, GRA serves as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets. This role serves as a key strategic partner with the Pharmaceutical R&D and Commercial teams and works closely with the broader Regulatory Matrix Team to conceive and deliver innovative regulatory strategies for assigned assets. The Director must be able to integrate aspects of strategic and operational Regulatory Affairs into asset development, collaborating with the cross functional team including Clinical Research, Biostatistics, Nonclinical, CMC, Diagnostics/Device, Commercial, etc. This role is responsible for leading preparations and delivery of Health Authority interactions, Clinical Trial Applications and Marketing Authorisations. In addition, they must proactively counsel teams, and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the medicine strategy, as well as driving or supporting efforts to shape the regulatory environment

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors or advanced degree in appropriate scientific discipline
  
• Minimum 5+ years of global regulatory experience in drug development and life-cycle management within Oncology. Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
  
• Leadership and strategic thinking capabilities
  
• Experience integrating regulatory science with scientific/clinical knowledge
  
• Track record of working in a global team and matrix organisation
  
• Strong written and verbal communications skills
  
• Excellent negotiation skills across levels within an organisation and with external stakeholders
  
• Experience managing multiple projects and proactively planning
  
• Experience in working with strategic partners/cross company collaborations
  
• Domestic and international travel ~10%
  
• Commute to work location with domestic relocation available for those meeting requirements
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master's Degree or PhD
  
• Experience of all phases of the drug development process in Regulatory Affairs
  
• Experience in partnering with business development in due diligence efforts
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​

​With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​

​Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​

*LI-GSK

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