Sr Manager, Global Regulatory Affairs
2 settimane fa
**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 ach
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