Senior Director, Global Regulatory Affairs, Vaccines

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Site Name: USA - Maryland - Rockville, Belgium-Wavre, Durham Blackwell Street, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

Posted Date: Aug 30 2023

Are you looking for a highly visible global regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this Senior Director role could be an exciting opportunity to explore.

The Senior Director Global Regulatory Affairs- Vaccines will focus on the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Position will have direct reports in multiple countries

Responsibilities And Accountabilities

Accountable to GRL (if not the GRL) and/or Global Regulatory TA Head for development of appropriate regulatory strategy(s) and for delivery according to plans with GSK Vaccines portfolios. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and including representing GSK with regulatory agencies as appropriate. Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the IAP and the Medicine Profile. Once prioritized by the MDT, work closely with the global commercial team and local regulatory teams in prioritized countries to secure the best possible labelling commensurate with available data and in line with the GDS.

Key Responsibilities:

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

• To proactively develop a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Ensure implementation of the regulatory strategy(s) in support of the project priorities.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
• Lead regulatory interactions and the regulatory review processes.
• Ensure effective interaction with local regulatory counterparts in priority markets and global commercial teams.
• Ensure compliance with regulatory requirements at all stages of product life
• Advocate persuasively to senior leaders in GSK and in Health Authorities
• Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
• If GRL, act as single point of accountability on the EDT/MDT, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s) associated with the IAP.
• Capable of providing critical regulatory assessment as part of due diligence/business development activities.
  
  

For Team Leaders:

• Direct line management responsibility.
• Ability to attract talent, challenge and manage and develop direct reports.
• Manage performance for direct reports (e.g. My Plan, Reward, Recognition, PIPs, etc.)
• Assist as needed in managing the Workforce plan and resource demands (including above project work and staff recruitment)
• Assist in managing TG budget.
  
  

Competencies And Capabilities

Leadership

• Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions.
• Supports team members to appreciate how their ideas can be combined in order to create value for the whole group. Ability to manage cultural diversity and be effective in leading global teams
• Ability to lead change and communicate difficult messages. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Ensures implementation of longer-term plans or delivery of large scale projects
• Proven ability to build strong personal networks, both within and outside GSK and use them to secure appropriate support and outcome for a project.
• Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Adds value through quantitative goal setting and provision of feedback to raise collective performance
  
  

Business Skills

• Delivers all communication with clarity, impact and passion, tailored to the audience. Commands attention and interest through the use of a range of communication techniques and styles. Makes complex ideas simple. Is able to effectively interact across all levels and areas within the company.
• Good listening and comprehension skills; ability to adapt personal style to a given audience; takes ownership and is productive in addressing potential problems before they become an issue
• Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations. Capable of synthesizing complex information globally to ensure appropriate assessment of the “big picture” for a project
• Proven ability to make sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints.
• Strong overall business acumen. Understands the needs of other functions. Understands the competitive landscape in the commercial and pre-commercial space.
• Ability to influence and manage conflict in a consensus building manner showing sensitivity to building productive business relationships; demonstrates excellent ability to have conversations in which there may be varying and different opinions or approaches/options.
  
  

Technical

• Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
• Strong overall development and clinical acumen. Good understanding of the diseases being developed.
  
  

Compliance

• Clear understanding of the importance of following all applicable laws and regulations and role modeling GSK expectations and values.
  
  

Why you?

Basic Qualifications:

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

• Bachelor’s degree in biological or healthcare science or related field
• 8 or more years of experience in all phases of the drug development process in regulatory affairs
• Experience in Vaccine therapeutic areas and developing product / therapeutic knowledge in new areas.
• Experience leading development, Regulatory submission and approval activities
• Experience in clinical trial and licensing requirements in global priority markets
• Experience leading direct reports
• Experience managing financial budgets
  
  

Preferred Qualifications:

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

• PhD in biological or healthcare science
• Prior Project Management leadership including for projects with little or no precedence.
• Ability to organize and execute successful milestone meetings and create relationships with one or more Health Authorities
• Has established an external network into other pharmaceutical companies and recognized internally and externally as an expert broadly, or in specific areas, of regulatory affairs.
• Excellent communication skills and ability to present strategy and solutions to senior leaders
• Ability to motivate and lead international teams
• Able to travel as needed outside of the United States
  
  

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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