The Manager, Regulatory Affairs, US Therapeutic Group
ensures the development of appropriate US regulatory strategy(s) for HIV & GSK's established products and their execution for assigned asset(s) and ensuring compliance with FDA regulatory requirements. Our Global Regulatory Affairs organization plays a critical role in enabling delivery of innovative biopharmaceuticals to patients.
As an integrated Global Regulatory Affairs team, our regulatory functions drive business-aligned, innovative regulatory strategies related to the discovery, development, registration, commercialization, and lifecycle management of products (pharmaceuticals and vaccines) that maximize the value of the R&D pipeline and our existing product portfolio in markets around the world. We also operate a continuous learning organization that recognizes the importance of proactive efforts to shape the evolving external regulatory environment in order to enable novel regulatory pathways for our portfolio of medicines.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Product responsibility for a set of established products
- Ensuring the regulatory strategy that will deliver the needs of the US
- Maintain the label for assigned products Partnership regional commercial and medical teams in the US and other teams within Global Regulatory Affairs
- Contribute to and/or lead the Regulatory Matrix Team
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's in an appropriate scientific subject with 5 plus years of experience in several phases of the drug development process in regulatory affairs
- Experience in several phases of the drug development process in Regulatory Affairs, with emphasis on life-cycle management of marketed products
- Experience of working as part of a multi-functional matrix team and/or leading a regulatory matrix team; experience in developing US regulatory strategy, completing submission and approval activities
- Experience of licensing requirements in the US
If you have the following characteristics, it would be a plus:
- Advanced Degree
- Excellent communication skills, ideally in writing and verbally.
- Proven ability to deliver key communications with clarity, impact and passion.
- Proven ability to foster strong matrix working both within the regulatory matrix team and as part of cross-functional teams ensuring regulatory matrix team input is sought on strategic decisions and recommendations
- Ability to lead through change
- Able to implement plans and hold self and team accountable for delivery of short- and medium-term goals
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:
*This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK
- 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.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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