Global Regulatory Affairs Manager, Vaccines Therapeutic Group

Job purpose:

As a Global Regulatory Affairs (GRA) Manager, you will join the GRA Vaccines Therapeutic Group in charge of the regulatory submissions on a project perspective.

You will provide a strategic approach in a multi-disciplinary life cycle management (LCM) environment.

Please note that 2 vacancies are open. Further details will be provided during the interview stage.

In this role you will...

• Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to the assigned portfolio.

• Interact with (or represents his/her area/product at) internal multidisciplinary project related teams, for all parts of RA aspects of a given project top line and in depth on procedural and clinical/labelling aspects.

• Lead multidisciplinary teams

• 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 procedural and clinical/labelling.

• 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 of regulatory documents, internal and external.

• Occasionally fulfil the role of N+1 review for regulatory documents.

• Provide input into the Global Regulatory Plan for one or more specific sections

• Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL

• Work with RA and non-RA stakeholders to ensure regulatory content is aligned with targeted overall profile of the product.

• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.

• Provide input to Vaccines Development Plans in order to optimize submission strategy; accountable for Procedural and Clinical RA aspects.

• Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;

• Occasionally 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 in line with the overall project plan and RA milestones.

Why you?

Basic Qualifications :

• Advanced Scientific Degree ( General Science or Life Science Degree )

• Significant experience in regulatory affairs, or appropriate relevant experience.

• Experience in clinical regulatory affairs.

• Ability to lead, coordinate and execute regulatory strategy for a given project/product.

• Strategic thinker, creative mindset – 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, maximise 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.

• Good 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

• Fluent in English, with excellent writing skills.

Preferred Qualifications:

• Ph.D. or M.D

• Previous experience in the development/ registration/lifecycle management of vaccines and obtaining licenses in different geographical areas is preferred.

Application closing date: Friday 15 November 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert.

#LI-Hybrid

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.

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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