Senior Manager Regulatory Affairs, Grl Delegate
il y a 3 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Mar 17 2023
As a Senior Manager Regulatory Affairs, GRL Delegate, you will have global responsibility (for Regulatory Affairs) for the development and lifecycle activities related to pneumococcal vaccines**.**
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
The role includes the following responsibilities:
The role includes the following responsibilities:
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to vaccines registration and lifecycle management.
- 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 clinical/labelling.
- 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 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.
- 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 optimise submission strategy; accountable for Clinical RA aspects.
- Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;
- 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 organisation of activities 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:
- Ph.D. or M.D Pharmacy, Chemistry, Biology or Medicine
- Senior Global Regulatory Manager: 6+ years significant experience in regulatory affairs, or appropriate relevant experience.
- Previous experience in the development/ registration/lifecycle management of vaccines and obtaining licenses in different geographical areas is preferred.
- Experience in managing teams and leading in a matrix organization.
- Ability to lead, coordinate and execute regulatory strategy for a given project/product.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 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.
- Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
- 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.
- Able to input into the Company’s regulatory positioning and write /critically review key documents targeting internal or external key audiences.
- In collaboration with relevant multidisciplinary stakeholders, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
**_ Why GSK?_*
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