- Provide regulatory strategic and/or operational support for combination products or drug delivery devices.
- Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Supply & Technology Solutions (S&TS) Teams) and advise on best practices and/or supports Commercial Teams, as assigned by the GRA-CMC & Devices Leadership Team.
- Lead/Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions
- Ensure effective communication of CMC regulatory strategy, risks, and overall plans to GRA Teams, S&TS Teams and Development and Commercial Teams.
- Lead or provide input to internal regulatory business initiatives and/or cross functional work streams.
- Bachelor's Degree, Master's preferred in a relevant life science or business-related discipline
- Many years of relevant experience including a broad background of registration experience gained from working in the pharmaceutical industry, preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or a regulatory authority in a CMC review capacity.
- Regulatory experience in combination products or drug delivery devices
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
- Extensive experience of participating in regulatory agency meetings on CMC matters
- Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
- Effectively lead globally diverse teams, meetings and discussions to deliver global/regional CMC sections of regulatory submissions for development and post-approval products
- Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
- Effective interpersonal, presentation and communication skills with established internal and external stakeholders
- Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.
-
Regulatory Cmc Scientist
1 week geleden
UCB Anderlecht, België**Make your mark for patients** · We are looking for a **Regulatory CMC Scientist - Small Molecules** to join us in our **Regulatory Affairs** team, based in any of the following locations: Brussels (Belgium) or Slough (UK) · **About the role** · Define the strategy, planning and ...
-
Senior Global Regulatory Cmc Scientist
5 dagen geleden
Keyrus Life Science Belgium Brussels, België**What we offer** · Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put t ...
-
Senior Scientist Cmc
1 dag geleden
Argenx Gent, België1. PURPOSE OF THE FUNCTION · A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim ...
-
Regulatory CMC Scientist
3 dagen geleden
UCB Anderlecht, BelgiëMake your mark for patients · We are looking for a Regulatory CMC Scientist – Small Molecules to join us in our Regulatory Affairs team, based in any of the following locations: Brussels (Belgium) or Slough (UK) · About the role · Define the strategy, planning and preparation ...
-
Associate Cmc Regulatory Scientist
6 dagen geleden
Ardena Gent, België**About us** · As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and ...
-
CMC Scientist
3 dagen geleden
Argenx Ghent, België Voltijdargenx is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE AntibodyTM platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us t ...
-
Senior Scientist CMC
3 dagen geleden
Argenx Ghent, België Voltijd1. PURPOSE OF THE FUNCTION · A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim ...
-
Regulatory Device Scientist
1 uur geleden
UCB S.A. Anderlecht, België**Make your mark for patients** · We are looking for a **Medical Device Regulatory Scientist** to join us in our **Regulatory Affairs** team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK), Atlanta/Raleigh (US) or Toronto (Canada) offices. · The Medical De ...
-
Qc Device
1 uur geleden
U C B Anderlecht, BelgiëWe are looking for a looking for a high caliber, self-motivated **, QC Device & Packaging Project Manager **To strengthen our **Internal Manufacturing **team **, based in our UCB Campus based in **Braine l'Alleud, Belgium. · **About the role** · As our new team member: · - You fa ...
-
Head of Analytical Sciences Portfolio
6 dagen geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Head of Analytical Sciences Portfolio** with good ability to collaborate and influence in a multidisciplinary team to join us in our Development Science organization based in Braine-l'Alleud, Belgium. · **About the role**: ...
-
Upstream Group Leader
1 week geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · We are looking for an **Upstream Group Leader (Late Stage)** to join us in our **Biologics DS Process Sciences** department, based in **Braine-l'Alleud**, **Belgium** · **About the role** · The Upstream (USP) Group Leader (Late Stage) will be res ...
-
Gene Therapy Downstream Process Sciences Senior
2 dagen geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Gene Therapy Downstream Process Sciences Senior Scientist** who's **dynamic, resilient and flexible** to join us in our **Gene Therapy Process Development** team, in **Belgium** · **About the role** · The **Gene Therapy (GT ...
-
Quality Partner Biotech Sciences Ops&qp
2 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Partner Biotech Science Ops & QP** based in **Braine l'Alleud, Belgium**. · **At UCB everything we do starts with a simple question: "How ...
-
Quality Partner Biotech Sciences Ops&qp
2 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Partner Biotech Science Ops & QP** based in **Braine l'Alleud, Belgium**. · **At UCB everything we do starts with a simple question: "How ...
-
Cmc Technical Documentation Solution Expert
1 dag geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our Product Strategy and industrial Impl. team, we are looking for a high caliber, self-motivated, CMC Technical Documentation Solution Expert based in Braine l'Alleud, Belgium · At UCB everything we do starts with a simple question ...
-
Gene Therapy Upstream Process Scientist
2 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Gene Therapy Upstream Process Scientist** who is **easy going** to join us in our **Gene Therapy CMC Process Development** team, based in **Belgium**. · **About the role** · The Gene Therapy (GT) Upstream Process Scientist ...
-
Gene Therapy Drug Product Scientist
2 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Gene Therapy Drug Product Scientist** who is a hands-on team player with a keen interest for innovation and a can-do attitude to join us in our **Gene Therapy Process & Analytical Sciences** team, based in **Belgium** (Brai ...
-
Gene Therapy Pcmd
1 week geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Gene Therapy Physico-Chemical Method Development (Senior) Scientist** who is **team and solutions oriented** to join us in our **CMC Gene Therapy Analytical Development** team, based in Braine-l'Alleud, **Belgium** · **Abou ...
-
Solid State Senior Subject Matter Expert
6 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients.** · We're here because we want to build the future and transform patients' lives for the better. · At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgro ...
-
Industrial Lead Analytical Associate
1 dag geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Product Strategy and Industrial Impl. team, **we are looking for a high caliber, self-motivated**, Analytical Project Lead **based in **Braine l'Alleud, Belgium.** · **At UCB everything we do starts with a simple question: "Ho ...
Regulatory CMC Scientist - Anderlecht, België - UCB
Beschrijving
Make your mark for patients
We are looking for a Regulatory CMC Scientist – Small Molecules to join us in our Regulatory Affairs team, based in any of the following locations: Brussels (Belgium) or Slough (UK)
About the role
Define the strategy, planning and preparation (writing and review) of CMC documentation and sections for regulatory submissions from a global/regional perspective to achieve timely approvals to meet business needs.
Who you'll work with
You will work within the Regulatory CMC Small Molecule team and partner with other technical functions across the business.
What you'll do
Interested? For this position you'll need the following education, experience and skills:
If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCB
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
