GSK

Global Regulatory Lead - Discovery & Early Development US RDC

Employer
GSK
Location
Rockville, Maryland; Research Triangle Park, North Carolina; Marietta, Pennsylvania; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Posted
February 15 2021
Ref
280336
Organization Type
Pharma
The Global Regulatory Lead-Discovery & Early Development US RDC will have global responsibility for Regulatory Affairs of a given Project(s)/Product(s), within GSK Vaccines.

The purpose of this job is to:

  • Manage regulatory activities in order to support vaccine assets in discovery and early development stages
  • Determine from a strategic and scientific perspective the content of technical, pre-clinical and clinical sections of product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Pediatric Investigational Plans) to ensure that these documents meet high scientific standards and regulatory requirements.
  • For transversal topics work with the RA function and region teams to ensure strategy and content is aligned with targeted overall profile of the product and/or technology.
  • Contribute, from an RA perspective, to the establishment of the product development strategy and its execution in order to ensure a complete and rapid development of the asset.
  • Provide 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.


KEY RESPONSIBILITIES:
  • Act as, or manage, the single point of Regulatory contact for Discovery Project Teams (DPTs) and/or Vaccine Development Teams (VDTs), as appropriate, plus other internal project related teams and possibly teams with the rest of GSK corporation
  • Participate to project discussions and provide strategic, scientific and RA input
  • Develop the asset specific regulatory strategy on a global scale
  • Global Regulatory Plan (GRP) ownership and accountability
  • Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities
  • Ensure that the content of product/portfolio specific regulatory documents is in line with GSK Vaccines (or corporate) objectives
  • Ensure high quality of product/portfolio specific regulatory documents submitted to Authorities and ensures that those documents meet regulatory requirements
  • Provide input to Vaccines Development Plans in order to optimise the Target Product Profile (TPP) and secure proper alignment of technical, clinical and non-clinical aspects and the use of appropriate regulatory procedures to secure the optimum submission strategy
  • Key driver for the discovery and development of the asset
  • Point of contact for Regulatory Agencies for asset(s)
  • Coordinate early interactions with key authorities to obtain input on clinical, technical and/or non-clinical development strategy and, as appropriate, on the optimal regulatory pathway to follow to secure registration and/or approval of regulatory submissions for the given asset(s)
  • Ensure in collaboration with the relevant RA function and region teams, as appropriate, the resources to ensure execute the agreed RA plan.
  • Develop and motivate collaborators so to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
  • Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).


MINIMUM QUALIFICATIONS:
  • BS & 8+ years of experience in managing regulatory projects.
  • Experience in the development of medicinal products and obtaining licenses in different geographical areas.


PREFERRED QUALIFICATIONS:
  • MS/PhD/MD
  • Strategic thinker - ability to connect different elements together.
  • Evidence of proactive leadership to identify issues and mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence
  • Good influencing and presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams, with other GSK divisions or during meetings with regulatory agencies.
  • Culturally aware.
  • Ability to manage individuals (including indirectly) 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.
  • Credible externally as the “face of GSK”
  • Recognized excellent communication skills, both oral and written.
  • Fluent in English, with excellent writing skills.
  • Able to develop Company's regulatory positioning, and write strategic documents targeting internal or external key audiences.


*LI-GSK

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