Director, Vaccine Mature Products, Cmc

2 settimane fa


Siena, Italia Glaxosmithkline A tempo pieno

Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMCLocation: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, PolandDirects key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK products.
Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles.Key Responsibilities include, but are not limited to:Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives.Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.Likely to have direct line management responsibility.
Coaches and mentors staff across CMC RA on lifecycle management in CMC.Responsible for managing budget and resource for their teams.
Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles.Successfully navigates internal/external networks.
Leads influences and motivates staff within and across departments.Commercially astute and organisationally aware and able to deal with sensitive and confidential issues.
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.Delivers CMC regulatory strategy to support major inspections (e.G.
PAI's) or quality incidents (LICs/PIRCs).Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company.
Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.Has accountability for submission content.
Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.Operates with independence.
Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Able to demonstrate the following key high-performance behaviours, customer driven, flexible thinking, and continuous improvement.Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.Proven project management and multi-tasking skills.Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.Demonstrated ability to handle complex global CMC issues through continuous change and improvement.Experience in leading major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).Preferred Qualifications:If you have the following characteristics, it would be a plus:Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.Identified as CMC Regulatory expert in a specific subject area.Proven experience in supervising and training staff within and across the organisation.Closing Date for Applications: 21st January 2025 (COB)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 Life at GSK | GSKPlease 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.#J-18808-Ljbffr



  • Siena, Italia Gsk A tempo pieno

    **Site Name**: Italy - Siena, Belgium-Wavre, UK - London - New Oxford Street, USA - North Carolina - Durham**Posted Date**: Jan 7 2025**Director, Vaccine Mature Products, CMC**:** Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland**Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management...


  • Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - Durham Posted Date: Jan 7 2025 Director, Vaccine Mature Products, CMC Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMCLocation: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, PolandDirects key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMC Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMC Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMCLocation: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, PolandDirects key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - DurhamPosted Date: Jan 7 2025Director, Vaccine Mature Products, CMCLocation: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, PolandDirects key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • Siena (SI), Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - Durham Posted Date: Jan 7 2025 Director, Vaccine Mature Products, CMC Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK...


  • Siena, Toscana, Italia GlaxoSmithKline A tempo pieno

    At GlaxoSmithKline, we are seeking a highly skilled and experienced professional to lead our CMC Regulatory Affairs team. In this key role, you will be responsible for directing strategic CMC regulatory activities across late development and the global lifecycle management of our products.The successful candidate will oversee a team ensuring compliance with...


  • Siena, Italia Gsk A tempo pieno

    **Site Name**: Belgium-Rixensart, GSK HQ, Italy - Siena, USA - Pennsylvania - Upper Providence**Posted Date**: Oct 14 2024**Job Purpose**:The Vaccines CMC Transversal Processes Lead will be responsible to diagnose, design, implement and embed enterprise continuous improvement projects within the scope of Vaccines Technical R&D (TRD) as well as maintenance of...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street, USA - Massachusetts - Boston, USA - Pennsylvania - Upper Providence **Posted Date**: Oct 25 2024 The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial...


  • Siena, Italia Gsk A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street, USA - Massachusetts - Boston, USA - Pennsylvania - Upper Providence**Posted Date**: Oct 25 2024The CMC Development Projects Regulatory Project Manager is responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle...


  • Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena **Posted Date**: Oct 3 2024 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...


  • Siena, Italia Gsk A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Canada - Ontario - Mississauga, Italy - Siena, Poznan Grunwaldzka, Warsaw Rzymowskiego 53**Posted Date**: Sep 25 2024As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing...


  • Siena, Italia Gsk A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Italy - Siena**Posted Date**: Sep 25 2024**Director, Pipeline Project Management - Vaccines**:Pipeline Project Management drives decisions and enables teams to choose the best path and deliver medicines to patients faster than ever.In GSK, the Pipeline Project Manager (PPM) will act as the 'COO'...


  • Siena, Italia TN Italy A tempo pieno

    Position summaryThe Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.Ability to translate...


  • Siena, Italia Seqirus A Csl Company A tempo pieno

    The Site Administrator provides a variety of activities in support to CSL Seqirus Italy site with expertise in areas such as facility maintenance, reception administration (filing), supplies, mail services, fleet and housekeeping.The role holder will also provide high level administrative support for the Managing Director/Board of Directors.Responsibilities...


  • Siena, Italia Csl Behring A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...


  • Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Belgium-Wavre, Italy - SienaPosted Date: Sep 6 2024Job purpose:Are you looking for a highly visible medical writing role that broadens your project management capabilities?If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.As a Medical Writing Asset Lead, you will lead therapy area specific medical writing...


  • Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Belgium-Wavre, Italy - Siena Posted Date: Sep 6 2024 Job purpose: Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider. As a Medical Writing Asset Lead, you will lead therapy area specific medical writing...