GSK

Global Regulatory Lead (Director) - Shingrix

Employer
GSK
Location
Rockville, Maryland; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Posted
March 30 2021
Ref
283460
Organization Type
Pharma
The Global Regulatory Lead-Shingrix 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 late stage development and life cycle management
  • 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 product strategy and its execution in order to ensure post approval commitments are met and life cycle management goals are reached.
  • 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 Vaccine Commercialization Teams (VCTs) and associated submission and work stream teams, as appropriate.
  • Participate to project discussions and provide strategic, scientific and RA input
  • Continue the development and execution of 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 Commercialization Plans in order to optimise the Target Product Profile (TPP) / Vaccine Profile and secure proper alignment of technical, clinical and non-clinical aspects and the use of appropriateregulatory procedures to secure the optimum submission strategy in new markets and support use in current markets.
  • Point of contact for Regulatory Agencies for asset(s)
  • Coordinate 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 rapid registration and/or approval of regulatory submissions
  • 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 biological 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.


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:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

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