Manager, Global Regulatory Affairs - MMRV
Position holder (PH) will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.
- 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 (e.g. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one specific (clinical/labelling or technical/NC or procedural) section.
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (e.g. Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labelling or technical/NC or procedural)
- Provide regulatory input for one (or more, in agreement with his/her manager) 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 a specific section (clinical/labelling or technical/NC 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
- 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 clinical/labelling or technical/CMC or procedural aspects of a given project.
- 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
- Provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects
- Provide support to the GRL via critical review of the clinical/labelling or technical/NC or procedural section of regulatory documents, GRPs and KMSs
- May fulfil the role of N+1 review as per RSBP for clinical/labelling or technical/NC or procedural-based documents
- Provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP)
- 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
- 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
- Provide input to Vaccines Development Plans in order to optimize 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
- 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
- May possibly 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 within the remits of his/her expertise area (clinical/labelling and/or technical/NC and/or procedural)
- 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 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
- Ensure planning and proper organization 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
Note : no direct reports
o Advanced Scientific Degree: General Science or Life Science Degree required in order to adequately execute responsibilities of Job
o Preferred level of education: Ph. D. or M.D. (Pharmacy, Chemistry, Biology or Medicine). Given the responsibility associated with the position and the need to ensure that advice and input is solid, a strong scientific basis is preferred
- Job related Experience
o 4+ years significant experience in regulatory affairs or appropriate relevant experience
o Broad knowledge is required and covers scientific as well as regulatory expertise
o Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred
o Previous experience in regulatory affairs within industry is required to ensure appropriate level of understanding of the RA activities and impact. The depth of experience required will depend on the level of the role that the incumbent will have (from contribution to the project in support of the GRL to own responsibility for part of the asset group)
- Other job-related skills/background
o Ability to coordinate and execute regulatory strategy for a given project/product
o Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy
o Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
o Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams
o Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate
o Good influencing skills
o Culturally aware
o Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
o Ability to resolve problems through resourceful use of information and contacts
o 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
o Quality mindset
o Fluent in English, with excellent writing skills
o Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences
o In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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