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Director, Vaccines Therapeutic Group- Global Regulatory Lead

Employer
GSK
Location
Rockville, Maryland
Salary
Competitive
Closing date
Oct 13, 2022
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Are you looking for a global regulatory affairs role that allows you to challenge your expertise, leveraging your strategic and scientific acumen in support of our vaccine assets? If so, this could be an exciting opportunity for you to explore.

The role is broad and very strategic with a fundamental impact on the products and projects.

Your expertise will influence and impact the following key responsibilities:

  • Act as the Global Regulatory Lead for Seasonal and Pandemic Influenza Portfolio.
  • Manage regulatory activities in order to support vaccine assets in discovery, early, late or life cycle stages of vaccine development. As of the early development stage, manage the regulatory activities in order to obtain Marketing Authorizations for commercial products as rapidly as possible, obtaining the best possible label, and to maintain these authorizations.
  • 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.
  • Act as, or manage, the single point of Regulatory contact for Discovery Project Teams (DPTs) and/or Vaccine Development Teams (VDTs) and/or Vaccine Commercial Teams (VCTs) as appropriate, plus other internal project related teams and possibly teams with the rest of GSK corporation.
  • Participate in 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 optimize the Target Product Profile (TPP) or the label and secure proper alignment of technical, clinical and non-clinical aspects and the use of appropriate regulatory procedures to secure the optimum submission strategy.
  • Communicate relevant asset specific information to enable colleagues (eg. DPLs, VDL, VCLs and LOC) to prepare the external environment in a timely fashion.
  • Key driver for the discovery and/or development and/or of the asset.
  • Point of contact for Regulatory Agencies for asset(s).
  • Assure efficient interactions with the regulatory authorities to achieve on-time input on the regulatory strategy or approvals of GSK Vaccines submissions for the 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.
  • Lead the regulatory team responsible for execution of the regulatory strategy for a project/product.
  • 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).


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Advanced Scientific Degree -General Science or Life Sciences concentration .
  • 8+ years significant experience in managing regulatory projects, or appropriate experience.
  • Able to develop Company's regulatory positioning, and write strategic documents targeting internal or external key audiences.
  • Very broad knowledge is required and covers scientific as well as regulatory expertise.
  • Direct experience in the development of medicinal products and obtaining licenses in different geographical areas.
  • Strategic thinker - ability to connect different elements together.
  • Evidence of proactive leadership to identify issues and mitigation strategies, maximize 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.
  • 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.
  • Fluent in English, with excellent writing skills.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ph.D. or M.D -area of specialization: Pharmacy Chemistry, Biology or Medicine.

Why GSK?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

~We Look Forward To Working With You !~

#LI-GSK

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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