Regulatory Affairs Manager

1 month ago


Ware, Hertfordshire, United Kingdom GSK Full time
Job Title: Regulatory Affairs Manager/Associate Director, CMC

Are you a seasoned regulatory affairs professional looking to drive strategy and shape integrated regulatory development across portfolios? This exciting opportunity at GSK could be the perfect fit for you.

About the Role:

As a Regulatory Affairs Manager/Associate Director, you will be responsible for leading regulatory submissions, interactions, and strategy related to products within the US. You will drive the CMC strategy, coordinate the timely preparation of technical regulatory documents, and identify risks to the business associated with submission data and information packages.

Key Responsibilities:
  • Develop and implement CMC regulatory strategies to support product development and lifecycle maintenance.
  • Lead and mentor cross-functional teams to ensure compliance with regulatory requirements.
  • Collaborate with internal and external stakeholders to shape the regulatory environment and drive business growth.
  • Provide strategic direction and data assessment to inform business decisions.
  • Ensure all CMC regulatory aspects are in place to avoid clinical holds and ensure continuity of market supply.
Requirements:
  • Bachelor's Degree in Life Sciences or associated discipline.
  • Experience in drug development and manufacturing, with a focus on complex worldwide CMC regulatory requirements.
  • Developing experience in major filing activities, such as MAA/NDA/BLA, significant manufacturing change, or key development interactions.
Preferred Qualifications:
  • PhD in Life Sciences or associated discipline.
  • Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership.
  • Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies.

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. 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).

We are an equal opportunity employer and adhere to affirmative action principles. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).



  • Ware, Hertfordshire, United Kingdom GSK Full time

    Job Title: Regulatory Affairs Manager CMCJob Summary: We are seeking a highly skilled Regulatory Affairs Manager CMC to join our team at GSK. The successful candidate will be responsible for driving CMC strategy, coordinating regulatory submissions, and interacting with regulatory agencies.Key Responsibilities:* Develop and implement CMC regulatory...


  • Ware, Hertfordshire, United Kingdom Saint-Gobain Formula GmbH Full time

    Job Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Saint-Gobain Formula GmbH. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for safety data sheets and labelling.Key Responsibilities:Ensure safety data sheets...


  • Ware, Hertfordshire, United Kingdom GSK Full time

    About the RoleGSK is seeking a highly skilled Regulatory Affairs Lead to join our team. As a Regulatory Affairs Lead, you will play a key role in shaping the regulatory strategy for our CMC products.Key ResponsibilitiesRegulatory StrategyDevelop and implement regulatory strategies for the CMC portfolio.Collaborate with cross-functional teams to ensure...


  • Ware, Hertfordshire, United Kingdom GSK Full time

    Job Opportunity:Are you a skilled professional looking to drive strategy and shape integrated regulatory development across portfolios? This Regulatory Affairs Management Manager/Associate Director role at GSK could be an ideal opportunity to explore.About the Role:This is a highly-visible US regulatory affairs role that allows you to drive strategy and...


  • Ware, Hertfordshire, United Kingdom GSK Full time

    Job Title: Regulatory Affairs Manager CMC Strategy DevelopmentThis role offers a unique opportunity to drive strategy and shape integrated regulatory development across portfolios within a highly-visible US regulatory affairs environment.As a Senior Regulatory Affairs Manager, you will be responsible for regulatory submissions, interactions, and strategy...


  • Ware, Hertfordshire, United Kingdom Saint Gobain Full time

    Regulatory Affairs, Safety Data Sheets, and Compliance RoleAt Farécla Products, part of the Saint-Gobain group, we are seeking a R&D Regulatory Specialist. This position will add significant value to the team with strong regulatory and compliance skills. The role also involves working in a laboratory where products are formulated.Key responsibilities...


  • Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time

    Company OverviewAt 1925 GlaxoSmithKline LLC, we are committed to unifying science, technology, and talent to get ahead of disease together. As a global biopharma company, our purpose is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.Job DescriptionWe are seeking an experienced CMC Regulatory...


  • Ware, Hertfordshire, United Kingdom Farecla Products Limited Full time

    Compliance and Research RoleThis is a unique opportunity to join Farecla Products Limited as an R&D Regulatory Compliance Specialist. The role combines regulatory affairs with hands-on research and development work in the company's on-site laboratory.We are seeking an experienced professional with extensive knowledge of regulatory SDS and labelling...


  • Ware, UK, Hertfordshire, United Kingdom Farecla Products Limited Part time

    Regulatory affairs, safety data sheets, compliance, labelling; You know these like the back of your hand! You have years of experience in these areas and have the ability to work autonomously, using your initiative, and enjoying a certain level of responsibility. How about working in the on-site R&D lab, hands on with the products, on top of this?At Farécla...

  • Project Manager

    1 month ago


    Ware, Hertfordshire, United Kingdom Wood Full time

    Wood is seeking a skilled Project Engineer to support the delivery of equipment and facilities on a client site in Ware.The ideal candidate will have a strong background in Pharmaceuticals or FMCG, with a HND/HNC in a relevant Engineering discipline and good knowledge of GMP within a Pharmaceutical Environment.Key responsibilities include:Managing...

  • Care Services Manager

    4 weeks ago


    Ware, Hertfordshire, United Kingdom Domus Recruitment Full time

    We are working with a reputable care provider to find a Home Manager to lead one of their Older People's services in Hertfordshire. As a professional ambassador for the home and the business, you will be responsible for ensuring the safe running of the home and maintaining a healthy work-life balance.Key Responsibilities:Develop and implement robust...


  • Ware, Hertfordshire, United Kingdom Investigo Full time

    Rare opportunity to lead a high growth business with a great product and amazing culture.You will be reporting into the Head of Finance and managing a small team whilst supporting the growth and quality of reporting required during an exciting growth journey.Key responsibilities include:Preparation of monthly, quarterly and annual financial and management...


  • Ware, Hertfordshire, United Kingdom Investigo Full time

    Rare opportunity to contribute to the growth of a high-performing business with a great product and culture.You will be reporting into the Head of Finance and managing a small team, supporting the growth and quality of financial reporting during an exciting growth journey.Key responsibilities include:Preparation of monthly, quarterly and annual financial and...


  • Ware, Hertfordshire, United Kingdom Investigo Limited Full time

    Rare opportunity to lead finance operations in a high growth business with a great product and amazing culture.You will be reporting into the Head of Finance and managing a small team whilst supporting the growth and quality of reporting required during an exciting growth journey.Key responsibilities include:Preparation of monthly, quarterly and annual...


  • Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Job DescriptionWe are seeking a highly skilled Human Factors Engineer to join our team in supporting the development of new drug-device combination products. The ideal candidate will have a strong background in human factors and usability, with experience in regulatory frameworks and design validation.Key Responsibilities:Provide human-centered design...


  • Ware, Hertfordshire, United Kingdom Fore Street Employment Agency Ltd Full time

    Job DescriptionFore Street Employment Agency Ltd is seeking a highly motivated and experienced Commercial Manager to drive business growth and manage commercial activities, focusing primarily on the UK and international Defence and Security markets.As the Commercial Manager, you will play a critical role in identifying and pursuing new business...


  • Ware, Hertfordshire, United Kingdom GSK Full time

    Job Title: Quality Assurance SpecialistThe Quality Assurance team at GSK plays a crucial role in ensuring the quality and compliance of our products. As a Quality Assurance Specialist, you will be responsible for reviewing and certifying finished products for release, ensuring that they meet all regulatory and cGMP requirements. You will work closely with...


  • Ware, Hertfordshire, United Kingdom Fore Street Employment Agency Ltd Full time

    Job DescriptionFore Street Employment Agency Ltd is seeking a highly skilled Commercial Manager to drive business growth and manage commercial activities, focusing primarily on the UK and international Defence and Security markets.The ideal candidate will have a strong track record in bid writing, business development, and commercial management, ideally with...


  • Ware, Hertfordshire, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time

    About the RoleAt GlaxoSmithKline Services Unlimited, we are seeking a highly skilled Technical Lead for Frontend Engineering Platforms to join our Respiratory Department. In this role, you will be responsible for delivering professional engineering expertise to support the Frontend (Micronising, Blending and Filling) of our production equipment, focusing on...

  • Process Lead

    1 month ago


    Ware, Hertfordshire, United Kingdom GSK Full time

    About the RoleWe are seeking a highly motivated and experienced Process Lead to join our team at GSK. As a key member of our Quality team, you will be responsible for developing and improving key quality processes to ensure compliance with regulatory requirements and industry best practices.Key ResponsibilitiesDevelop and implement quality processes to...