Global Regulatory Affairs Manager, Vaccines

1 settimana fa

Siena, Italia GSK A tempo pieno

**Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53
**Posted Date**: Oct 31 2024
**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 spe

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