Oferta pracy

MSR Coordination Regulatory Manager

GSKAbout the company

  • Poznań

    Poznań, Greater Poland
  • Offer expired a month 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 MSR projects by timely delivering high quality MSR packages,

  • Ensure high standard of submissions, act as subject matter expert in MSR process and quality control point;

  • Identify risks to quality and/or timely completion of projects, 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 manager to drive standardization across the business.

Our requirements

  • Documented track of relevant experience in regulatory area, CMC regulatory experience is preferred,

  • Capability to build and maintain a team,

  • Master’s degree in scientific or technical field,

  • 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.

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

  • Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer

  • Healthcare benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services, company car)

  • Career at one of the leading global healthcare companies

  • Supportive & friendly working environment

  • 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

  • Life Insurance

  • Sport and recreation cards

  • Annual Bonus

  • Canteen for employees at site (with discounts).

  • Flexible working options available for most positions.

GSK

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

The MSR Coordination Regulatory Manager is accountable for leading and managing the team delivering market specific requirements (MSRs) documentation in support to various regulatory applications, in line with existing business needs, strategies, goals and objectives. Regulatory Manager cooperates with GRPD’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRPD’s goals.

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