Global Regulatory CMC Scientist - Small Molecule (US)

UCB Hapeville, GA, GA
regulatory cmc scientist regulatory cmc patients strategy people regulatory strategy lead team disease manager
December 14, 2022
UCB
Hapeville, GA, GA
FULL_TIME

Make your mark for patients.


We're here because we want to build the future and transform patients' lives for the better. To achieve that, we need the brightest minds and biggest hearts. That's why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?


Hiring manager: Tim Van Engelgem, Global Regulatory Lead


About UCB


At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients' lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.


Everything we do starts with a simple question: "How will this make a difference to the lives of people living with severe diseases?" And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.


To strengthen our Regulatory Affairs Group, we are looking to fill the position of: Global Regulatory CMC Scientist - Small Molecules


What We Offer


An opportunity to:



  • Take responsibility for the regulatory CMC support of Small Molecule products throughout the Life-Cycle.

  • Define strategy, planning and preparation of regional specific Quality 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 Lead and agreed with the GRA Leadership Team and the operating units.


About the Role


You will be responsible for:



  • 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 Quality 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 Teams, Supply & Technology Solutions (S&TS) Teams, Development and Commercial Teams as agreed with the Global Regulatory CMC Lead.

  • Identifying supporting Quality documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.

  • Regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, Veeva Vault, etc.) within defined timelines.

  • Leading or providing input to internal regulatory business initiatives and cross functional work streams as assigned


About You


You should have:



  • Bachelor's Degree, Master's preferred in a relevant life science or business-related discipline.

  • Relevant Regulatory Affairs CMC experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.

  • Preferably some 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 biological and/or 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

  • Experience of direct communication and negotiation with regulatory agencies on CMC matters

  • Experience of participating in regulatory agency meetings on CMC matters

  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools


Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.


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