Senior Regulatory Specialist, Country Labelling

2 tygodni temu

Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat
The Senior Regulatory Specialist, Country Labelling is responsible for coordinating, communicating and maintaining regional/country labelling documents and data in regulatory systems according to defined standards and processes. The role involves providing support to GRA Labelling colleagues, Regulatory Matrix Teams, and Local Operating Companies to ensure timely update, management, and communication of quality regional and local labelling/Product Information (PI) and supporting documentation for local submissions.In this position as Senior Regulatory Specialist, Country Labelling, you will be tasked with:
  • Authoring and compiling Regional/Country PI following regulatory authority labelling requirements and GSK process and standards.
  • Developing market-specific supporting documentation for labelling submissions in line with regulatory authority requirements and GSK process and standards.
  • Supporting global and local GRA team members by preparing other labelling documents as needed.
  • Conducting quality and consistency checks of labelling document content.
  • Effectively managing labelling documentation and data in regulatory systems.
  • Providing advice on regulatory authority labelling requirements and GSK labelling process to GRA global/local roles and via Regulatory Matrix Teams.
  • Communicating with GSK staff for authoring, compiling, and delivering quality labelling documents. This may include communication with Regulatory Agencies and third parties on behalf of GRA labelling staff.
  • Supporting other regulatory functions and engaging in projects and activities as required, including leading changes to labelling processes and evaluating new agency labelling requirements.
  • Performing translation of labelling text into identified languages for some roles.
Requirements:
  • Relevant experience in the pharmaceutical industry, life sciences research, or regulatory field.
  • Masters degree in Science or Life Sciences (mandatory).
  • Experience working in a regulated or quality-critical environment, such as pharmaceutical industry research, pharmacy, safety, or regulatory.
  • Understanding of labelling and experience in updating/managing Regional/Country Labeling documents.
  • Knowledge of labelling regulations/requirements in at least one region, with a preference for EU experience.
  • Attention to detail, significant document and database management experience, strong organization and time management skills.
  • Excellent written and verbal English communication skills, able to present information clearly and concisely to diverse global colleagues.
  • Flexibility to adapt to shifting priorities and timelines, understanding of the pharmaceutical industry and regulatory processes.
  • Ability to negotiate solutions for labelling issues and proactively identify process improvements.
What we offer:
  • Opportunity to work at a leading global healthcare company.
  • Hybrid work model - office presence required 2/3 days per week.
  • Employment contract with attractive benefits package.
  • Annual bonus, awards for outstanding performance, recognition for achievements and engagement, holiday benefits.
  • Life insurance, pension plan, and private medical package with additional healthcare services.
  • Sports card, opportunities for development within the company's structure.
  • Personalized learning approach through mentoring and online training platforms.
  • Extensive support for work-life balance, health, and well-being activities.
  • Modern office environment with various amenities like fresh fruits, car and bike parking, locker rooms, and showers.
Why GSK?

Bringing together science, technology, and talent to stay ahead of disease collectively.

GSK is a global biopharma company with a mission to leverage science, technology, and talent to proactively combat disease and enhance the health of billions while ensuring sustainable shareholder returns. The company focuses on preventive and therapeutic healthcare solutions utilizing vaccines, specialty, and general medicines, concentrating on immune system science and new platform technologies in four core therapeutic areas.

Our success hinges on our people, who are at the core of our disease prevention and treatment ambitions, as well as our commitment to creating a supportive and inclusive work environment where individuals can excel and grow. Join us on this journey to get Ahead Together if you share our vision.

GSK is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse and inclusive workplace. All candidates will receive equal consideration based on merit without regard to various protected classes.

Important notice to Employment businesses/Agencies

GSK does not engage with employment businesses or agencies for referrals; they must seek authorization before recommending candidates for GSK roles. Unauthorized actions by these entities will not be recognized by GSK.

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