Oferta pracy

Regulatory Specialist

GSKAbout the company

  • Kolorowa 2, Poznań
    Poznań, Greater Poland
  • Offer expired a month ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

GSK

Kolorowa 2

Poznań

Your responsibilities

  • Manage routine assigned projects, analyze regulatory strategy with your own input, 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 PSC,

  • Communicate regularly with Regulatory Manager 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 manufacturing sites, 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.

Our requirements

  • Relevant experience in regulatory affairs and pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD format),

  • Bachelor’s degree in chemistry, pharmacy, chemical technology or other related science or technical field,

  • Fluent Polish and English (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 clearly and effectively, work in a diverse team environment and build relationships across a large organization.

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

What we offer

  • Our values and expectations are at the heart of everything we do and form an important part of our culture.

  • These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness.

  • 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

Regulatory Platform Centers in GlaxoSmithKline are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers and regulatory information management. Regulatory Platform Centers provide regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

We are looking for a Regulatory Specialist to join GMS Programs team. In this role you will have an opportunity to work closely with a team supporting significant Pharma Supply Chain (PSC) centrally driven change programs. The Team provides dedicated support to ensure regulatory changes for key PSC initiatives are progressed timely and efficiently. The Team is responsible for preparation of technical documentation for regulatory changes globally, providing responses to Regulatory Agency questions and expertise in the regulatory requirements for global source changes/CMC variations on Active Pharmaceutical Ingredients (API), Intermediates and Drug Product as well as other PSC-driven initiatives.

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