Current jobs related to CMC Regulatory Affairs Leader - Ware, Hertfordshire - 1925 GlaxoSmithKline LLC

  • CMC Development Projects Lead

    2 weeks ago

    Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    **Job Description**This Chemistry, Manufacturing and Controls (CMC) Development Projects Regulatory Project Manager role could be an ideal opportunity to explore.You will work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to...

  • Childcare Leader

    2 weeks ago

    Ware, Hertfordshire, United Kingdom Partou Full time

    Establish a nurturing environmentWe are seeking an experienced Childcare Leader to join our team at Partou Sucklings Yard.As a Childcare Leader, you will be responsible for creating a safe and supportive environment for children and families.At Partou, we are committed to providing exceptional care, compassion, and continuous learning. These values guide our...

  • Medical Device Risk Management Lead

    3 days ago

    Ware, United Kingdom CK GROUP Full time

    CK Technical are recruiting for a Medical Device Risk Management Lead to join a company in the biopharmaceutical industry at their site based in Ware on a permanent basis. **The Company**: Our client is an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel...

  • Team Leader

    10 hours ago

    Ware, United Kingdom ivolve Care and Support Full time

    **About You**: Can you lead the way? You’re a natural leader and organiser. You inspire your team to be the best they can be, and you’re warm and approachable too. If that’s you, then we’re already big fans. It’s great if you have an NVQ level 3 in Health and Social - but don’t worry if you haven’t, we’ll help and support you to gain this...

  • Senior Support Worker

    7 months ago

    Ware, United Kingdom ivolve Care and Support Full time

    **Vacancy Location**: Ware, Hertfordshire. SG12 7DU **Shifts**: Monday - Sunday on a rota basis **Pay Rate**:£26,863 per annum (based on 42 hours per week) **Sponsorship**:This service does not provide support for Sponsorship at this time **About You** You’re a natural leader and organiser. You inspire your team to be the best they can be, and...

  • Document Controller

    7 months ago

    Ware, United Kingdom John Wood Group Full time

    Wood is a global leader in consulting and engineering, helping to unlock solutions to critical challenges in energy and materials markets. We provide consulting, projects and operations solutions in 60 countries, employing around 35,000 people. Wood is recruiting for a Document Controller to join its Process & Energy team, focusing on collection,...

  • Assistant Manger Ware

    7 months ago

    Ware, United Kingdom ivolve Care and Support Full time

    **Vacancy Location**: Based at Ware, Hertfordshire SG12 7DU but also covering Stansted, Harlow, Sheering, Bishops Stortford services **Shifts**: 37.5 - 42 hours per week - Monday to Sunday on a rota basis **Pay Rate**: £24,960.00 To £27,955.20 per annum **Sponsorship**: This service does not provide support for Sponsorship at this time **About...

CMC Regulatory Affairs Leader

2 months ago

Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time
Company Overview

At 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 Description

We are seeking an experienced CMC Regulatory Affairs professional to lead our efforts in lifecycle management for biopharmaceutical products. The ideal candidate will have a strong background in regulatory affairs, with expertise in post-approval filing activities, complex worldwide CMC regulatory requirements, and project management skills.

Key Responsibilities
  1. Represent Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing strategic direction and guidance to Supply Chain, Quality Assurance, and Commercial teams.
  2. Identify key risks to the business associated with submission strategy and information packages, and develop well-defined risk mitigation strategies.
  3. Lead and manage cross-functional teams, ensuring compliance with GSK policies and procedures, staff development, and training to deliver roles.
  4. Manage budgets and resources for teams, and ensure effective organizational networks and leadership.
  5. Collaborate with senior management to influence the internal/external regulatory environment and drive business-critical activities.
Estimated Salary Range:

$120,000 - $180,000 per year, depending on experience and location.

Required Skills and Qualifications

The successful candidate will have:

  • BSc in Life Sciences or related scientific discipline with 5+ years of Post Approval CMC Regulatory experience for biopharmaceutical products.
  • Experience leading major post-approval filing activities for biopharmaceutical products.
  • Knowledge of biopharm drug development and manufacturing processes.
  • Strong communication and influencing skills, with the ability to negotiate with regulatory agencies and industry bodies.
  • Able to work independently and operate at a high level of autonomy.
Benefits

As a member of our team, you can expect:

  • A comprehensive benefits package, including medical, dental, and vision insurance.
  • A retirement savings plan, with employer matching contributions.
  • Generous paid time off, including vacation, sick leave, and holidays.
  • Ongoing training and professional development opportunities.
Why Join Us?

At 1925 GlaxoSmithKline LLC, we offer a dynamic and supportive work environment that fosters innovation and collaboration. We are committed to diversity, equity, and inclusion, and strive to create a workplace where everyone feels valued, respected, and empowered to succeed.