Manager, Regulatory Affairs, CMC Vaccines

GSK
Siena, Toscana
3 giorni fa
Site Name: Belgium-Wavre, GSK HQ, India - Karnataka - Vemgal Bangalore Site, Italy - Siena, Poznan Business Garden, Rixensart, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence, Ware, Warsaw
Posted Date: Jul 31 2025

About the role

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

About the 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 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.

About you

Minimum Level of Job-Related Experience Required

  • 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.
  • Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

Preferred Level of Job-Related Experience Required

  • 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).

#LI-GSK
#GSKVaccines

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 organisation 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 wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

Apply
Other Job Recommendations:

Junior Nonclinical Regulatory Affairs

Evotec
Provincia di Verona, Veneto
  • Prepare and review Nonclinical Tabulated Summaries, in...
  • Draft and critically review nonclinical regulatory...
3 settimane fa

Stage Regulatory Affairs

Amgen
Milan, Lombardia
  • For Centralized Procedures: translation and review of texts...
  • For Mutual Recognition/Decentralized Procedures: management...
1 settimana fa

Medical Affairs Scientist - Internal Medicine (12 months secondment)

Pfizer
Roma, Lazio
  • Glocal Member, scientific and clinical support to Global ...
  • Developing local medical strategy...
1 settimana fa

Director, Regulatory Policy & Intelligence

Organon Pharmaceuticals
Città Metropolitana di Roma Capitale, Lazio
  • Provide Global Regulatory Policy and Intelligence insights...
  • Represent Organon at key meetings and discussions on...
1 settimana fa

Civil Affairs Planner (IO Planner)

Leidos
Provincia di Vicenza, Veneto
  • Conduct PMESII-PT, DIMEFIL, and operational design...
  • Collaborate with interagency partners (e.g., State...
1 settimana fa

Restaurant Manager Pizzikotto - Opportunità a MILANO CELIO

CIGIERRE Compagnia Generale Ristorazione SpA
Milan, Lombardia
Esperienza in gestione ristorante o settori affini (retail, GDO) Esperienza in pianificazione e budget, con focus sui KPI...
3 giorni fa

Regulatory Affairs Specialist (Sostituzione Maternità)

Viatris
Milano, Lombardia
  • Gestione di un portafoglio prodotti comprendente procedure...
  • Valutazione tecnica del CTD_Modulo 3 e suo aggiornamento...
2 settimane fa

Legal Affairs Senior Manager

Prysmian Group
Milan, Lombardia
  • Review, analyze, comment and draft a wide variety of EPCI,...
  • Introduce templates for contracts where appropriate Advise...
2 settimane fa

Client Solutions Manager, QSR/Supermarkets - Global Business Solutions, Italy

TikTok
Milan, Lombardia
Working with the top agencies and brands across Europe to educate and inform about the exciting evolution of TikTok. - Present...
3 settimane fa