Global Regulatory CMC Scientist - Small Molecule

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Global Regulatory CMC Scientist – Small Molecules

UCB – Inspired by patients. Driven by science.

Help us transform patients’ lives.

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/Medical Device support of Small Molecule products containing a medical device constituent 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/Medical Device input to all Health Authorities (HA) interactions on CMC and/or Medical Device 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/Medical Device 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/Medical Device 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/Medical Device 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 and/or the Global Regulatory Devices 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/Medical Device 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/Medical Device experience in the pharmaceutical industry or a regulatory authority in a CMC/Medical Device 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/Medical Device 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/Medical Device matters
• Experience of participating in regulatory agency meetings on CMC/Medical Device matters
• Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news