- 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 - Slough, United Kingdom - UCB
Description
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
I nterested? For this position you'll need the following education, experience and skills :
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