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Regulatory Cmc Scientist
Il y a 3 mois
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
- 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.
nterested? For this position you'll need the following education, experience and skills:
- 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 postapproval products
- Demonstrated competence in contributing on crossfunctional teams and operating within a matrix organisational structure
- Effective interpersonal, presentation and communication skills with established internal and external stakeholders
- Proven leadership, problemsolving ability, flexibility, influence, and effective teamwork skills.
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.