Oferta pracy

Submission Coordination Regulatory Manager

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired 11 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • team manager

Your responsibilities

  • manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment,

  • support submissions for new and marketed Pharma and Vaccines Products by timely delivering high quality applications,

  • ensure high standard of submissions,

  • identify risks to quality and/or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level,

  • drive continuous process improvement within areas of your influence,

  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,

  • build and maintain quality relations with your internal and external stakeholders,

  • work closely with your peers and Marketed or New Products Heads to drive standardization across the business.

Our requirements

  • Documented track of relevant experience in Regulatory Affairs area, experience in CMC, Post Approval Regulatory or Registration of New Product is preferred,

  • Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field

  • Capability to build, motivate and maintain a team,

  • Fluent English and Polish (both verbal and written),

  • Strong interpersonal and communication skills,

  • Ability to perform multiple tasks, set the right priorities to deliver objectives on time,

  • Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.

  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

  • Knowledge of drug development and manufacturing and supply processes.

  • Knowledge of worldwide CMC regulatory requirements

  • Experience with project management (submissions coordination)

  • Global/ EMAP Regulatory submission experience - knowledge of regulatory agency guidelines as an asset

Optional

  • well-developed leadership skills,

  • negotiation and problem solving skills,

  • practical knowledge of risk management,

  • Project Management experience would be an asset.

What we offer

  • Important and interesting job in one of the leading global healthcare companies.

  • Possibility to work with engaged and enthusiastic people from various locations.

  • Access to newest technologies and solutions.

  • Possibilities of development within the role and company’s structure.

  • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).

  • Corporate culture based on our values: patient focus, integrity, respect and transparency.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

GSK

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer.

Content Delivery in GlaxoSmithKline is a cross-functional regulatory affairs team focused on delivery excellence, provides regulatory expertise to internal and external partners and delivers high quality content at different stages of the biopharma product lifecycle so that GSK’s medicines and treatments get to patients faster.

Step up to the new challenge and take the lead in a diverse international regulatory environment. Bring a real value to our Patients worldwide by having a high level of impact on delivery of the early and late-stage pipeline and ensuring product license continuity through high quality and timely regulatory submissions delivered by your Team.

As the Submission Coordination Regulatory Manager, you will be accountable for leading and managing the team responsible for delivery of submissions for products in development and/or marketed products to agreed timeframes and appropriate content in compliance with Regulatory Authorities regulations, guidance’s and with GSK SOPs and working practices, and in line with existing business needs, strategies, goals and objectives.

You will cooperate with internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall departmental objectives.

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