Regulatory Lead for Project Switch

2 tygodni temu

Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat
Regulatory Lead for Project Switch

Support the deployment of the MAH strategy for Trading Partners, including Regulatory Submissions activities, operations, compliance, and governance aspects.

  • Support the delivery of the MAH strategy within Trading Partners
  • Support in management and oversight of the regulatory project
  • Liaise with and be the contact for the CRO single point of contact
  • Manage the regulatory plan for the project, working closely with the CRO, LOCs, and other impacted GSK functions
  • Manage progress reporting and project risks, including to the Regulatory Governance Board
  • Third Party Governance Framework support (including generation of KPIs)
  • Manage communication planning
  • Lead working group meetings
  • Documents retention - all important and/or legally valuable regulatory electronic and/or hard copy documentation and/or information and/or job registries are stored according to local practice and requirements
  • Participation in mandatory training and completion of training records
  • Participation in relevant internal/external Audits, if applicable

Basic Qualifications:

  • Degree in a scientific discipline (life sciences / pharmacy / professions aligned with medicine)
  • Relevant experience in Regulatory Affairs
  • Knowledge of the policies and regulatory climate in Europe
  • Experience across various regulatory activities
  • Managed large and complex projects and/or previous line or matrix management
  • Proactive and solution-focused approaches to work constructively with the PM regulatory team and Partners
  • Excellent communication skills and ability to work with a cross-functional team
  • Understanding of supply chain and artwork processes
  • Well-organized ways of working and prioritization skills
  • Ability to quickly and efficiently learn new ideas and concepts
  • Fluent English language skills (speaking and writing)

At GSK we offer a wide range of additional benefits:

  • Career at one of the leading global healthcare companies
  • Fix term contract of employment (12 months with the option to be prolonged)
  • Hybrid work (2/3 days per week from the office)
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
  • Life insurance and pension plan
  • Private medical package with additional preventive healthcare services for employees and their eligible
  • Sports cards (Multisport)
  • Possibilities of development within the role and company's structure
  • Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
  • Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits every day

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their well-being. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.

Important notice to Employment businesses/Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect to the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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