Sr Manager, Global regulatory affairs

Job content

Site Name: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena, Philadelphia Navy Yard, UK - United Kingdom

Posted Date: Jul 12 2023

Are you interested in a highly visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Manager could be an ideal opportunity to explore.

As a Regulatory Affairs Manager, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.

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

• Provide input to/manage regulatory activities in order to obtain Marketing Authorizations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations.
• Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Pediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling and/or technical/NC and/or procedural) section(s).
• Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one or more specific sections (clinical/labelling and/or technical/NC and/or procedural).
• Provide regulatory input for one or more specific sections of certain/all development stages of the project/product within a given product portfolio.
• Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for one or more sections (clinical/labelling and/or technical/NC and/or procedural)
• Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
• May act as lead or N+1 within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team.
  
  

Key Responsibilities:

• Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
• Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for all parts of RA aspects of a given project top line and in depth on clinical/labelling or technical/NC or procedural aspects.
• Participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on clinical/labelling or technical or procedural aspects.
• Provide input into the asset specific regulatory strategy on a global scale.
• Provide support to the GRL via critical review of one or more specific sections (clinical/labelling and/or technical/NC and/or procedural) of regulatory documents, GRPs and KMSs.
• May fulfil the role of N+1 review as per RSBP.
• Provide input into the Global Regulatory Plan (GRP) for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections.
• Coordinate (for one or more specific (clinical/labelling and/or technical/NC and/or procedural) sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL.
• For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product.
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling and/or technical/NC and/or procedural) and ensure that those documents meet regulatory requirements.
• Provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy; contributes for clinical/labelling and/or technical/NC and/or procedural and accountable for one of the RA aspects.
• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and technical/NC and procedural and accountable for one or several of the RA aspects.
• May act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
• Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s).
• In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL.
• Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
• Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
• Ensure planning and proper organization of activities (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.
  
  

Why you?

Basic Qualifications:

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

• Bachelor’s degree in life sciences or related scientific discipline
• 5+ years’ experience with either drug or vaccine development.
• 5+ years’ experience with regards to worldwide regulatory requirements.
• 5+ years’ experience in project management skills and the ability to manage and direct multiple projects.
• 5+ years Line management experience
• 3+ years of experience with FDA, EMA and other health authority filings.
• 3+ years of global regulatory strategy development
  
  

Preferred Qualifications:

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

• Master’s degree or doctorate in life sciences or related scientific discipline
• 5+ years working with, influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues’ personnel in a variety of settings.
• Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines marketed product support.
• Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings.
• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
• Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence.
• Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner.
• Ability to resolve problems through resourceful use of information and contacts.
• Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• Able to input into the Company’s regulatory positioning and write /critically review key documents targeting internal or external key audiences.
• In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
• Good influencing skills.
• Culturally aware.
• Quality mindset
• Fluent in English, with excellent writing skills.
  
  

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, rigor 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.
  
  

#WYARD2022

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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