Regulatory CMC Scientist Small Molecules
Regulatory CMC Scientist Small Molecules
Date: May 31, 2019
Location: Anderlecht, Brussels, BE
Help us transform patients' lives.
At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Global Regulatory CMC team, based in our headquarter in Brussels, Belgium, we are looking to fill the position of: Regulatory CMC Scientist - Small Molecules Marketed Products
Are you analytical with innovative capacities? At UCB that makes you an 'analyvative' person. This unique blend of talent means you are good at processing facts to forge new solutions for patients.
As a UCB 'analyvative' person and Regulatory CMC Scientist - Small Molecules Marketed Products you like to work in an environment where you can:
* Take responsibility for the regulatory CMC support of Small Molecules products throughout the Life-Cycle *
* Define strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs *
* Leading and/or provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions as delegated by Global Regulatory CMC Scientist and agreed with the GRA Practice Leadership Team and the operating units
As a UCB 'analyvative' person and Regulatory CMC Scientist - Small Molecules Marketed Products you will contribute by:
* Developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy
* Taking "Hands-on" accountability by managing CMC projects yourself and writing regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines *
* Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Practice Teams, TSO Practice Teams and PVUs as agreed with the Global Regulatory CMC Lead
Interested? For this position you'll need the following education, experience and skills:
* Educated to a Masters level, in a relevant life sciences or business related discipline *
* At least 5-8 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 5 years of experience in Regulatory Affairs CMC and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
* Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new chemical entities
* Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products *
* Extensive experience of direct communication and negotiation with regulatory agencies on CMC matters *
* Extensive active participation in regulatory agency meetings on CMC matters *
* Knowledge of GMP requirements and standard systems (e.g. change management systems and tools) *
* Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
* Excellent interpersonal skills
UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system - or the central nervous system.
With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a 'can-do' attitude can thrive. Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.
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