Manager, Global Regulatory Affairs

Job content

Site Name: Belgium-Wavre, USA - Maryland - Rockville, Italy - Siena
Posted Date: Mar 15 2021

As a Manager, Global Regulatory Affairs will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.

The Purpose Of The Job Is To

• 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/labelling 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/labelling 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/labelling or t/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.
  
  

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• 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.
• 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
• 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.
• 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)
• 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/labelling or technical/NC or procedural) 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 in Pharmacy, Chemistry, Biology or Medicine
• 4+ years significant experience in regulatory affairs, or appropriate relevant experience
• 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
• Fluent in English, with excellent writing skills.
  
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• 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.
• 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
  
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.
  
  

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