Regulatory Affairs Manager, GRL Delegate - Influenza

‘Be You’ at GSK (for external posting only) At GSK, we’re a company with a purposeto help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively.

As Manager Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.

• You interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project.

• You participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of given project.

• You provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects.

• You provide support to the GRL via critical review of the clinical/labelling or technical/NC or procedural section of regulatory documents, GRPs and KMSs.

• You may fulfil the role of N+1 review as per RSBP for clinical/labelling or technical/NC or procedural-based documents.

• You provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP).

• You coordinate (for one specific clinical/labelling or technical/NC or procedural part) 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.

• You compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or technical/NC or procedural sections) and ensure that those documents meet regulatory requirements.

• You provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC or clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects.

• You facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects

• You may possibly act as the point of contact for Regulatory Agencies for asset(s) (project-specific)

• You 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, you escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her expertise area (clinical/labelling and/or technical/NC and/or procedural).

• You must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).

• You develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.

• You ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.

Basic Qualifications

• Advanced Scientific Degree

• 4+ years significant experience in regulatory affairs

• Ability to coordinate and execute regulatory strategy

• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact

• Ability to identify and escalate issues and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence

• Good presentation, communication and influencing skills

• Culturally aware

• 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.

• Quality mindset

• 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.

• Fluent in English, with excellent writing skills.

• Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences.

Preferred Qualifications:

• Ph.D. or M.D

• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.

• Knowledge of German would be a plus

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

• Li-GSK

VxRD*

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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