Head International Cmc Regulatory Affairs
2 days ago
The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy and leadership across the product lifecycle.
The role possesses strategic leadership skills and has the depth of knowledge and experience within the CMC Regulatory environment.
Influential in cross-functional discussions with relevant senior internal and external stakeholders to deliver the overarching international CMC regulatory strategy for AstraZeneca's medicines portfolio.
This is across development and commercial products, to secure approval, ensure continuity of drug supply and maintain regulatory compliance.
The position has significant impact on achievement of AstraZeneca's financial and business goals.
What you will do: You will partner with Research, Development & Operations experts to build innovative strategies for development of current and future drug portfolio and identify activities to define effective regulatory strategy on a global basis.
You will contribute to the strategic development of the International CMC Regulatory Affairs function, collaborating with senior colleagues across Regulatory Affairs, R&D and Global Operations to ensure overall strategic alignment to meet AZ's portfolio goals.
You will work with Operations Supply Chain leadership to define strategy and priorities for optimisation of commercial supply chain for a portfolio of products.
Attend Supply Committee as needed providing Regulatory input into proposals impacting global supply.
Essential Skills/Experience: Experience in Regulatory Affairs, with focus on CMC.
Other relevant experience in the pharmaceutical industry, for example in CMC Development, Quality Control, Manufacture, or relevant roles in Regulatory Agency.
Strong strategic thinking and influencing skills at all levels across cultural interfaces.
Significant experience in leading and developing teams of people.
Ability to establish and foster excellent cross-functional collaborations and communicate at multiple levels of the organization.
Strong leadership skills working in an international environment.
Strong communication and interpersonal skills.
Develops People and Organisation - builds capability for the organisation.
Desirable Skills/Experience: Experience of leading or contributing to significant change programs.
Experience of Product Development, DPOM and associated resource requirements.
Extensive in-depth knowledge of regulatory procedures and processes.
Why AstraZeneca?
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe.
As Regulatory professionals working on products, we take innovative Regulatory approaches to bring life-changing treatments to patients.
We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
Turn our pipeline into reality to impact patients
Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process.
Next Steps?
Are you ready to step up and take ownership of your work, solutions for the business and your personal career development?
Apply now and join us in our mission to bring life-changing medicines to people
Location: Cambridge UK Salary: Competitive + Excellent Benefits Date Posted: 29-Nov-2024 Closing Date: 06-Dec-2024 Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
#J-18808-Ljbffr
-
Associate Director, Regulatory Affairs Cmc
3 hours ago
Cambourne, United Kingdom Bicycle Therapeutics Full timeThis job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.Bicycle molecules are fully synthetic short...
-
Senior Director Regulatory Affairs
18 hours ago
Cambourne, United Kingdom Cpl Life Sciences Full timeJob Description Job Title: Senior Director, Regulatory Affairs Job Type: Full-time, permanent position Location: Cambridge, UK – Hybrid Remuneration: £130,000 + Benefits Cpl Life Sciences is collaborating with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with...
-
Associate Director, Regulatory Affairs
4 days ago
Cambourne, United Kingdom Moonlake Immunotherapeutics Full timeJob Purpose As an Associate Director, Regulatory Affairs, you are an integral part of MoonLake's team and will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).You will be responsible for regulatory aspects related to product development and approval, in alignment with the global business...
-
Regulatory Affairs Manager
2 weeks ago
Cambourne, United Kingdom Dr. Reddy'S Laboratories Full timeCompany Overview: Dr. Reddy's Laboratories Ltd. ("Dr.Reddy's") is a leading multinational pharmaceutical company based across global locations.Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait .Location: Dr. Reddy's (UK) Ltd,...
-
Regulatory Affairs Manager
4 days ago
Cambourne, United Kingdom Dr. Reddy'S Laboratories Full timeCompany Overview: Dr. Reddy's Laboratories Ltd. ("Dr.Reddy's") is a leading multinational pharmaceutical company based across global locations.Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.Location: Dr. Reddy's (UK) Ltd,...
-
Graduate Regulatory Science Apprenticeship
2 weeks ago
Cambourne, United Kingdom Vcls Full timePost-Graduate Regulatory Science Apprenticeship with VCLS In conjunction with TOPRA, we are offering a Post-Graduate Regulatory Science Apprenticeship.This is an opportunity for a recent graduate with an interest in medicines and a desire to build a career in Regulatory Affairs.You will embark on a 30 month programme that combines comprehensive Regulatory...
-
Regulatory Affairs Manager
18 hours ago
Cambourne, United Kingdom Dr. Reddy'S Laboratories Full timeJob Description Company Overview: Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's") is a leading multinational pharmaceutical company based across global locations.Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait .Location: Dr. Reddy's...
-
Head Of Compliance
2 days ago
Cambourne, United Kingdom Vertex Ventures Hc Full timeCompany Description Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...
-
Eu Policy And Public Affairs Officer
2 weeks ago
Cambourne, United Kingdom Ad Warrior Full timeEU Policy and Public Affairs Officer If you think you are the right match for the following opportunity, apply after reading the complete description.Location : UK hybrid working, with regular travel to Brussels, Strasbourg and European capitals.Salary: £39,479 to £45,827 per annum (Depending on experience) Our clients mission is to make the internet a...
-
Eu Policy And Public Affairs Officer
2 weeks ago
Cambourne, United Kingdom Ad Warrior Full timeEU Policy and Public Affairs Officer Location : UK hybrid working, with regular travel to Brussels, Strasbourg and European capitals.Salary: £39,479 to £45,827 per annum (Depending on experience) Our clients mission is to make the internet a safer space for children across the globe.They tackle this mission head-on, working tirelessly to find and remove...
-
Eu Policy And Public Affairs Officer
1 week ago
Cambourne, United Kingdom Ad Warrior Full timeEU Policy and Public Affairs Officer Location : UK hybrid working, with regular travel to Brussels, Strasbourg and European capitals.Salary: £39,479 to £45,827 per annum (Depending on experience) Our clients mission is to make the internet a safer space for children across the globe.They tackle this mission head-on, working tirelessly to find and remove...
-
Head Of Communications
18 hours ago
Cambourne, United Kingdom Wellcome Genome Campus Full timeJob Description The Wellcome Genome Campus, located nine miles south of Cambridge, is a leading hub for genomic and biodata sciences, situated within a renowned life science cluster.Owned by a world-class endowment fund, the Campus is undergoing a major expansion, growing from 125 acres to 440 acres to become a global centre for cutting-edge science.This...
-
Cambourne, United Kingdom Vertex Ventures Hc Full timeCompany Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural...
-
Policy Manager
6 days ago
Cambourne, United Kingdom Internet Watch Foundation Full timeDo you enjoy conducting in-depth research and developing policy positions?Do you thrive on delving deep into complex policy issues and driving meaningful change?Are you passionate about shaping the future of online safety for children within the UK and internationally?If so, the Internet Watch Foundation (IWF) has an exciting opportunity for you.Reporting to...
-
Senior Manager Of Medical Writing
2 weeks ago
Cambourne, United Kingdom Al Solutions Full timeLiam Newton has partnered with a mi-sized Biopharma who are searching for a Senior Manager of Medical Writing.This business has a range of products already commercialised, and has a robust pipeline across a range of Therapeutic Areas.This company is committed to long term career development, and they can offer a very strong salary package.Responsibilities:...
-
Policy Manager
2 weeks ago
Cambourne, United Kingdom Ad Warrior Full timePolicy Manager Location : Cambridge Salary: £50,977 to £65,005 per annum (Depending on experience) Job Type: Full-time, 2-year fixed term contract The organisations mission is to make the internet a safer space for children across the globe.They tackle this mission head-on, working tirelessly to find and remove child sexual abuse material from the...
-
Policy Manager
1 week ago
Cambourne, United Kingdom Ad Warrior Full timePolicy Manager Location : Cambridge Salary: £50,977 to £65,005 per annum (Depending on experience) Job Type: Full-time, 2-year fixed term contract The organisations mission is to make the internet a safer space for children across the globe.They tackle this mission head-on, working tirelessly to find and remove child sexual abuse material from the...
-
Ad Warrior | Policy Manager | Cambridge
6 days ago
Cambourne, United Kingdom Ad Warrior Full timePolicy Manager Location : Cambridge Salary: £50,977 to £65,005 per annum (Depending on experience) Job Type: Full-time, 2-year fixed term contract The organisations mission is to make the internet a safer space for children across the globe.They tackle this mission head-on, working tirelessly to find and remove child sexual abuse material from the...
-
Head Of Financial Accounts
1 week ago
Cambourne, United Kingdom Your World Recruitment Group Full timeJob Title: Head of Financial Accounts Location: East England & East Anglia Hybrid: Minimum 2-days onsite Sector: Healthcare Department: Finance Salary: Band 8b Job type: Temporary Duration of booking: Expected to be for 6months Pay Rates £27.50 - £31.00 Paye Per Hour £30.50 - £34.00 Paye Inclusive of Holiday Per Hour £34.00 - £39.00 Umbrella Per Hour...
-
Product Development Manager
18 hours ago
Cambourne, United Kingdom Cycle Pharmaceuticals Full timeJob Description Product Development Manager, Commercial (Cambridge, UK) The Opportunity Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Product Development Department as a Product Development Manager, Commercial.The role will be responsible for providing technical and analytical knowledge of Cycle's...