Regulatory Specialist
Stiefel Laboratories, Inc
woj. wielkopolskie, Poland
3 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).

In this role you have an opportunity to work closely with GMS Programs Team that is in place to support significant Global Manufacturing and Supply (GMS) centrally driven change programs.

The Team provides dedicated support to ensure regulatory changes for key GMS initiatives are progressed timely and efficiently.

The Team is responsible for preparation of a technical documentation for regulatory changes globally and expertise in the regulatory requirements for global source changes on Active Products Ingredients (API), Intermediates and Drug Product as well as other GMS initiatives.

In your new role you will :

  • Manage routine assigned projects, analyze the strategy with own input, and provide comprehensive data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and local markets’ requirements
  • Deliver multiple challenging source changes on API, Intermediates and Drug Product and other programs driven by GMS including Wave 1 submissions
  • Communicate regularly with Regulatory Manager / Team Lead to help in identification of any issues with business impact
  • Identify improvement opportunities for CMC Regulatory processes, policies and systems
  • Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements
  • Interact with global regulatory groups and GSK Local Operating Companies in markets worldwide to deliver compliant and timely dossiers
  • Build and maintain good relationships with your internal and external stakeholders
  • Have training and mentoring responsibilities
  • Basic qualifications :

  • approximately 2 years of experience in pharmaceutical industry and regulatory affairs,
  • Bachelors degree in chemistry, pharmacy or other related science or technical field,
  • fluent Polish and English (both verbal and written),
  • ability to handle multiple tasks to prioritize and schedule work to meet business needs,
  • flexible and analytical thinking to independently provide solutions to issues,
  • detail-oriented, with emphasis on accuracy and completeness,
  • excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.
  • understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
  • Preferred qualifications :

    Please check Basic Qualifications

    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.

    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.

    Thank you very much for your interest in development opportunities with GlaxoSmithKline.

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