Overview
Site Name: Italy - Siena; Belgium - Wavre; Poznan Grunwaldzka; UK – London – New Oxford Street.
Posted Date: Oct *******
Job Description
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our Life at GSK page.
Locations:
Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland
Scope
Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.
Responsibilities:
Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with applicable regulatory and scientific standards.
Interpret regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products to advise teams and expedite submissions.
Ensure all appropriate CMC regulatory aspects for product release are in place to ensure continuity of market supply and that lifecycle submissions meet regional requirements.
Work in cross-functional matrix project teams with regulatory, development, quality and manufacturing to define proper regulatory CMC filing strategy.
Maintain high quality standards and pursue continuous improvement and innovation in response to evolving regulatory environments.
Share regulatory compliance best practices within CMC Regulatory teams and other impacted functions.
Engage in CMC Subject Matter Expert activities internally to increase compliance, harmonisation and efficiency.
Deliver CMC regulatory strategy to support major inspections with managerial support.
Why you?
Basic Qualifications:
Bachelor or Master Degree in life sciences or related scientific discipline.
Regulatory Affairs Certification (RAPS).
CMC regulatory affairs or product development experience with involvement in regulatory submission preparation in late phase development and/or marketed product lifecycle submissions.
Knowledge of drug development, manufacturing processes and supply chain; may have a specialized area of expertise.
Knowledge of worldwide CMC regulatory requirements and a track record of delivering compliant dossiers, particularly for marketed products.
Fluent English, written and spoken.
Preferred Qualifications
Note:
The following skills are preferred but not required.
If not available, please still apply.
Time management and ability to plan, prioritize and coordinate multiple tasks to meet deadlines.
Growth in global regulatory affairs and understanding evolving trends and policies across regulatory functions.
Experience influencing and negotiating with company personnel and regulatory agencies.
Strong interpersonal, presentation and communication skills with internal networks.
Potentially identified as CMC Regulatory expert in a specific subject area.
Proactive in suggesting process improvements; ability to develop and implement regulatory strategies and assess impact on project strategy.
Experience handling global CMC issues through change and improvement.
Developing experience in major post-approval filing activities.
What we offer
Permanent contract in an inclusive environment
Lavoro da remoto up to 50% for eligible roles
Performance Reward
Flexible Benefits
Company Healthcare Plan
Integrative pension fund
Employee Assistance Programme
Prevention services and vaccination clinic
Tax assistance
Local nursery agreement
Postal service, laundry, shoe repair and tailoring
On Site Gym
On Site canteens and coffee corners
Free company bikes and shuttle
Closing Date
Closing Date for Applications – 5th of November
Relocation note:
Please note relocation support cannot be provided; therefore, only candidates already based in the indicated country can be considered.
Application Instructions
Please take a copy of the Job Description, as it will not be available post closure of the advert.
When applying, describe how you meet the competencies for this role in your cover letter or CV.
The information provided will be used to assess your application.
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