Manager, Global Regulatory Affairs - HETV
* Requisition ID: WD167163
* Position: Full-Time Regular
* Open date: May 17, 2018 9:47 AM
* Functional area: Regulatory
* Required degrees: Not Indicated
Select Locale Email a friend
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 Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
* Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labeling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. 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/labeling or technical/NC or procedural) section.
* 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 specific section (clinical/labeling or t/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/labeling 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/labeling 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/labeling 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/labeling or technical/NC or procedural aspects.
* Provide support to the GRL via critical review of the clinical/labeling 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/labeling or technical/NC or procedural-based documents.
* Provide in-depth input on clinical/labeling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP).
* Coordinate (for one specific clinical/labeling 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/labeling or technical/NC or procedural sections) and ensure that those documents meet regulatory requirements.
* Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC or clinical/labeling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labeling and/or technical/NC and/or procedural aspects.
* Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labeling 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/labeling 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 organisation of activities (for one of RA specific activities within clinical/labeling or technical/NC or procedural) in line with the overall project plan and RA milestones.
Why You?Basic qualifications:
* Advanced Scientific Degree: General Science or Life Science Degree. Required in order to adequately execute responsibilities of the job.
* 4+ years significant experience in regulatory affairs, or appropriate relevant experience.
* Broad knowledge is required and covers scientific as well as regulatory expertise.
* Previous experience in regulatory affairs within industry is required to ensure appropriate level of understanding of the RA activities and impact.
* Fluent in English, with excellent writing skills.
* Preferred Level of Education: Ph.D. or M.D in 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.
* Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.
* Ability to coordinate and execute regulatory strategy for a given project/product.
* Strategic thinker - 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
* Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
* 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.