Manager, Clinical Regulatory Affairs

Conteúdo do emprego

Site Name: Belgium-Wavre
Posted Date: Jul 23 2021

We are currently recruiting a Manager, Clinical RA.

Key Responsibilities

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product
• You interact with (or represents his/her area/product at) internal project related teams (e.g. CRT, SRT, etc.) and possibly project teams (PTs), for clinical/labelling or procedural aspects of a given project.
• You participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or procedural aspects of given project
• You provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or procedural aspects
• You provide support to the GRL via critical review of the clinical/labelling or procedural section of regulatory documents, GRPs and KMSs
• You may fulfil the role of review as per RSBP for clinical/labelling or technical/NC or procedural-based documents
• You provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP)
• You coordinate (for one specific clinical/labelling or procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• You compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or procedural sections) and ensure that those documents meet regulatory requirements
• You provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or procedural aspects
• You 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
• You may possibly act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
• You 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, you 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 procedural)
• Yo must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s)
• You 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
• You 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
• You work in high performing matrix teams with the different GRA groups and beyond, to ensure alignment to the overall project plan and RA milestones.
  
  

Why you?

Basic Qualifications

• Advanced Scientific Degree: General Science or Life Science Degree
• 4+ years significant experience in regulatory affairs or appropriate relevant experience
• 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 Qualifications

• Preferred level of education: Ph. D. or M.D. (Pharmacy, Chemistry, Biology or Medicine)
• 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, maximize 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

Li-GSK

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

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.

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 specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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