In this role one will ensure the development of appropriate regulatory strategy(ies) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Evidence Plan (IEP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile.
Key Responsibilities
Accountable to Global Regulatory Lead (GRL) (if not the GRL) and/or Global Regulatory therapy area Head for development of appropriate regulatory strategy(ies) and for delivery according to plans. 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 IEP 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. In performing the role, the job holder will be responsible for:
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(ies) 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 Health Authority submission/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 with 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
Capable of providing critical regulatory assessment as part of due diligence/business development activities
Team Management
Direct line management responsibility.
Ability to attract talent, challenge and manage and develop direct reports
Manage performance for direct reports
Assist as needed in managing the Workforce plan and resource demands (including above project work and staff recruitment)
Assist in managing Team 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
Basic Qualifications
Bachelor’s degree in biological or healthcare science
Several years of experience in Global Regulatory Affairs
Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area.
Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority
Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region.
Preferred Qualifications
Masters or PhD
Ideally, 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.
Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making at the highest levels of R&D and with external partners.
Proven ability to drive process improvement in a matrix environment and with demonstrated leadership in the application of innovative approaches with portfolio-level impact.
A strong sense of initiative, urgency, drive, pragmatism, and judgement – an ability to make things happen.
Ability to deliver to demanding deadlines whilst maintaining the highest quality.
*LI-GSK
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 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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affir…directive principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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.*(US only).
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