Regulatory Affairs CMC Manager, Mature Products

Site Name:
Italy - Siena

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 webpage
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Scope
Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.

In this role, you will:

• 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 the applicable regulatory & scientific standards.
• Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
• Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
• Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Bachelor or Master Degree in life sciences or related scientific discipline.
• Regulatory Affairs Certification (RAPS).
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
• Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
• Fluent English both written and spoken.

Preferred Qualifications:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Good time management skills with the ability to effectively plan, prioritise and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
• Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
• Strong interpersonal, presentation and communication skills with established internal networks.
• May be identified as CMC Regulatory expert in a specific subject area.
• Proactively seeks out and recommends process improvements.
• Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
• Demonstrated ability to handle global CMC issues through continuous change and improvement.
• Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).

What we offer:

• Permanent contract in a very Inclusive environment
• Smart Working 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 for Applications – 5th of November
Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.
*Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
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*Why GSK?

Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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