Director, Therapeutic Group, Global Regulatory Affairs

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. 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 for appropriate US 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.
  
• Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
  
• Experience managing multiple projects and proactively plan
  
• Ability to travel domestically and internationally ~10%
  
• Able to 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:

• Masters or PHD
  
• Experience of all phases of the drug development process in Regulatory Affairs
  
• Experience in working with strategic partners/cross company collaborations
  
• Experience in partnering with business development in due diligence efforts
  
• Demonstrated leadership capabilities and ability to think strategically
  
• Ability to integrate regulatory science with scientific/clinical knowledge
  
• Demonstrated 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
  

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, rigour 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

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