Regulatory Team Lead, Market Specific Requirements
GSK
Poznań,Poland
6 d. temu

Your Responsibilities :

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 Team provides dedicated support to ensure timely delivery of market specific requirements (MSRs) for submission activities assigned to the License Maintenance and Market Expansion (LMME) team.

In this role you have an opportunity to work closely with internal and external stakeholders on MSRs projects supporting license renewals, regulatory changes, first registration applications for an established products and other submissions globally.

The Regulatory Team Lead reports to MSRs & PREPs Regulatory Manager and is accountable for leading and managing the team delivering market specific requirements (MSRs) in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licences worldwide.

Regulatory Team Lead 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.

In your new role as the Regulatory Team Lead you will :

  • 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 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
  • Basic qualifications :

  • Min. 3 years of experience and sound understanding of pharmaceutical industry and regulatory processes, especially in CMC regulatory affairs
  • Capability to build and maintain a team
  • Bachelor’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
  • Preferred qualifications :

  • Well- developed leadership skills
  • Negotiation, problem solving and innovation skills
  • Practical knowledge of risk management
  • Project Management experience would be an asset
  • Why GSK? : We offer :

    We offer :

  • Established job in one of the leading global healthcare companies
  • Access to newest technologies and solutions
  • Possibilities of development within the role and company’s structure
  • Non-wage benefits (private medical healthcare, life insurance, sports card)
  • Free parking area and company canteen
  • Work culture based on respect, honesty, transparency and focus on patient / consumer’s needs
  • GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies.

    So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business.

    Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

    You may apply for this position online by selecting the Apply now button.

    Closing date for applications : 19.10.2018

    When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

    Contact information :

    You may apply for this position online by selecting the Apply now button.

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