GSK

Vaccines Manager, Global Regulatory Affairs

Employer
GSK
Location
Rockville, MD
Salary
Competitive
Posted
November 18 2020
Ref
270610
Organization Type
Pharma
Job Type
Manager
Do you have experience in all aspects of a Regulatory Affairs project, supporting technical/ CMC, clinical, nonclinical and procedural aspects of strategy and submissions, but are looking to take this to the next level, supporting a best in class vaccine as we expand into new markets and maintain current licenses ? As part of the Global Regulatory Affairs (GRA) team you will support and have input into the vaccine asset specific global regulatory strategy across all disciplines within GRA. You will be a key part a fast paced, high-achieving team, delivering high profile approvals and label extensions, visibly contributing to the GSK mission of helping people do more, feel better, live longer. Ready for a challenge? If so, this Vaccines Manager of Global Regulatory Affairs role could be an ideal opportunity to explore.

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.
  • 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 optimise 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 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:
  • Advanced Scientific Degree
  • 4+ years significant experience in regulatory affairs, or appropriate relevant experience.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD or PharmD
  • Broad knowledge is required and covers scientific as well as regulatory expertise.
  • Previous experience in the development of biological products, preferably vaccines, and obtaining and maintaining licenses in different geographical areas is preferred.
  • Ability to coordinate and execute regulatory strategy for a given project/product (as development path)
  • Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy (as development path)
  • 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 (as development path)
  • Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams (as development path)
  • Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
  • Experience in the use of document management systems and project tracking (i.e., Regulatory Information Management systems).


Why GSK?

Our values and expectationsare 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • 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.


*LI-GSK

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