Director, Regulatory Affairs CMC Small Molecule, Mature Products
2 weeks ago
Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a robust and innovative product pipeline? If so, this role is an exciting move to explore.
GSK has a large, well established and largely in-commercial-supply portfolio in our mature, small molecule products. From a global regulatory perspective, this is a critical position to support this business area in the maintenance of compliant licenses globally, including our internal and external network, which enable continuity of supply. To do so, you will lead a team of managers and product owners, supporting them in the maintenance of license registration, empowering partnerships with manufacturing sites, local and regional regulatory partners, Quality and other stakeholders throughout the business. Together, you will support assessment of risks and issues, providing solutions which enable reliable production and registration of our products.
This is an extremely varied and fast paced area of the business, offering the successful candidate a true breadth of experiences. The position requires technical knowledge, but also significant interpersonal and communication ability. You will need to be flexible, resilient, and adaptable as a result, but success will lead to a high amount of visibility and the chance to build positive relationships throughout the GSK network. Additionally, we need someone who can operate with significant independence and autonomy in this role, meaning you will have the chance to drive improvements and results to best meet the needs of the company. You will fit into a cohesive team of fellow directors, all with a shared focus on capability. It is a high priority to upskill our talent, aid the development of others and then ensure their knowledge and capability is most efficiently deployed.
Key Responsibilities include, but are not limited to:
Representing Global CMC Regulatory, on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to other functional areas on both global project and key strategic business initiatives.
Creation, maintenance and continuous improvement of CMC Regulatory processes, policies, and systems, including the design and implementation of any new standards or procedures.
Delivering CMC regulatory strategy to support major inspections or quality incidents, taking an active role in any business-critical activities as required.
Understanding, interpreting, and advising on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of products, aiming to expedite submission and approval of CMC applications.
Ensuring appropriate strategies for CMC aspects of product release and stability are in place to ensure continuity of supply.
Directing project activities and strategies for multiple projects, including communication of risk mitigation strategies to senior management.
Leading, influencing, and motivating staff within and across departments, essentially leading the company position on internal/external CMC Regulatory.
Direction and communication of complex regulatory issues at senior levels, including internally and with external agencies and third parties.
Basic Qualifications:
Minimum requirements for success in the role:
Bachelor’s degree in Chemistry, Pharmacy or related scientific area of concentration.
Drug Development, manufacturing, and supply processes background.
Complex worldwide CMC regulatory requirements experience, including negotiating with regulatory agencies.
Leading a regulatory CMC team, including training and development.
Preferred Qualifications:
Masters or PhD in life sciences or related scientific discipline
Awareness and continued pursuit of knowledge regarding global regulatory affairs trends and policies
A CMC Regulatory expert in a specific subject area
#LI-GSK
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.
-
Compliance Manager
6 days ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Head Vaccines CMC Project
2 weeks ago
Brentford, United Kingdom 1849 GlaxoSmithKline Biologicals S.A. Full timeJob purpose: As the Head of Vaccines (Vx) CMC Project and Portfolio Management you are accountable for all operational aspects of Vx CMC project and portfolio delivery internally and externally including budget, risk, resourcing, planning, reporting and strategic capability development. This role will support effective project delivery of Technical...
-
Associate Director
5 days ago
Brentford, United Kingdom GSK Full time**Site Name**: UK - London - Brentford, Switzerland - Zug **Posted Date**: Feb 16 2024 Global/Regional Publications Associate Director The Global/Regional Publications Associate Director will Lead the establishment of Strategic Publications Plans alignment with overall medical communication strategy and objectives for a given asset and in alignment with...
-
Brentford, United Kingdom GSK Full time**Site Name**: Baar Onyx, GSK House, Upper Providence **Posted Date**: Feb 22 2023 The Global Medical Affairs Lead (GMAL) will be at the forefront of GSK’s re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely with their peers in Clinical Development, Clinical Research and Commercial...
-
Senior Engineering Manager
4 weeks ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeSite Name: UK - London - Brentford, Bangalore, Irvine, Poznan Business Garden Pastelowa, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, Warsaw Cirrus We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. our Performance with...
-
Director, Regulatory Data
6 days ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeSite Name: UK - London - Brentford, Home Worker - USA, USA - Pennsylvania - Upper Providence We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us,...
-
Executive Assistant
5 days ago
Brentford, United Kingdom Frances Taylor Foundation Full time**Job Title**: Executive Assistant **Salary**: £27,000 - £32,000 dependent on experience **Location**: Brentford, West London **Hours of Work**: 37.5 hours per week **Shift Patterns**:Monday to Friday - 8am-4pm/ 9am-5pm **The Role** We have an exciting opportunity for an Executive Assistant to assist in developing the support function for a group of...
-
Director, Safety and Pharmacovigilance
3 weeks ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeSite Name: UK - London - BrentfordPosted Date: Apr 4 2023Director, Safety and Pharmacovigilance ViiVViiV Healthcare is an independent, global specialist HIV company that is committed to delivering innovative new options for the care and treatment of people living with HIV/AIDS. ViiV is 100% dedicated to HIV medicines and research, and completely focused on...
-
Abpi Global Medical Signatory
5 days ago
Brentford, United Kingdom GSK Full time**Site Name**: UK - London - Brentford **Posted Date**: Aug 4 2023 **ABPI Global Medical Signatory**: **Location: GSK House (Brentford) OR possibility to work remotely**: **Job Purpose** The ABPI Medical Final Signatory role is primarily to provide both medical and compliance support for internal stakeholders through projects such as copy approval,...
-
Snr Director, Security Architecture
1 week ago
Brentford, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Associate Director, Scientific Communications
2 weeks ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeSite Name: GSK House, USA - Pennsylvania - Upper Providence We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest...
-
Customer Experience Delivery Manager
2 weeks ago
Brentford, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Cx Scrum Master
7 days ago
Brentford, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Manufacturing Manager
2 weeks ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Technology Director, Remote
2 weeks ago
Brentford, Greater London, United Kingdom GlaxoSmithKline Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
-
Corporate Development Manager
3 weeks ago
Brentford, United Kingdom Verisure Full timeVerisure is Europe's fastest-growing monitored security company and continues to strengthen its presence in South America. This rapid expansion and ongoing success is expected to continue. As a result, Verisure is reinforcing its Group Finance team with an exciting, rewarding, and impactful position to support its ambitious growth plan. Verisure is seeking...
-
Kit Assistant
7 days ago
Brentford, United Kingdom Brentford Football Club Full time**Job Title: Kit Assistant** **Department: Football Operations** **Reporting: B Team Kit Manager** **Location: Brentford FC Training Ground, TW5 0TP** **Salary**:* £22,000 - £25,000 per annum* **The Role of the Kit Assistant** Reporting to the B Team Kit Manager, the Kit Assistant will support with the provision of providing high-quality apparel and...
-
Senior Civil Designer
4 weeks ago
Brentford, United Kingdom Energy Resourcing Full timeOverview: Energy Resourcing are currently recruiting several Senior Civil Designer to join our client's Redcar project delivery team on a long-term PAYE contract or staff basis. Our client boasts several major international companies in a variety of fields including energy generation, recycled plastic, biofuel products as well as the manufacture of...
-
Software Engineer
4 weeks ago
Brentford, United Kingdom MFK Recruitment Full timeOur client based in West London is seeking a Software Engineer - C++, Unreal Engine to join their team. My client delivers systems that can perceive and understand the world with the same semantic richness as the human brain and using the exact neural mechanisms they believe are at work in the brain. Their approaches are inspired by their recent advances...
-
CX Delivery Manager
2 weeks ago
Brentford, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full timeWe’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...
