Job Purpose:
Ensure the development of appropriate regulatory strategies and their execution for assigned Vaccines asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Key Responsibilities:
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategies and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategies. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
You will:
Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
Implement the regional strategies in support of the project globally
Lead regulatory interactions and the review processes in local region
Ensure appropriate interaction with regional commercial teams in local region
Ensure compliance with regional requirements at all stages of product life
Advocate to senior leaders in GSK and in Health Authorities
Provide assessment of potential in license molecules
Leadership
Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project. Developing an external network
Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets
Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions.
Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short- and medium-term goals
Business Skills
Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques.
Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree: Biological or Healthcare Science
5 or more years industry regulatory affairs experience
5 or more years leading matrixed teams across global regions
Previous experience working in Vaccines
Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
Proven experience of leading regional development, submission and approval activities in local region(s). Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
PhD in Biological or Healthcare Sciences
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, 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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
The annual base salary for new hires in this position ranges from $166,650 to $277,750 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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