CMC Scientist - United States
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- 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 this pioneering adventure?
- To strengthen the CMC Center of Excellence in our Global Regulatory Affairs unit, we are looking to fill the position of CMC Scientist to be responsible for defining strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs.
As a 'energanized' person and CMC Scientist you like to work in an environment where you can:
- Proactively share knowledge with others.
- Take initiative and work towards creating patient value, rather than merely completing a task.
- Align efforts toward a common purpose to ensure maximum impact for patients.
- Generously offer help and resources to others in the interest of the business
As a 'energanized' person and CMC Scientist 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.
- Ensuring that the regional CMC regulatory strategy for the assigned projects/products are consistent with the GRA Practice, TO Practice Teams and PVU goals and objectives and meets HA requirements in assigned regions.
- Identifying supporting documents required for regional submissions and negotiating the delivery of approved technical source documents in accordance with project timelines.
- Writing regional and global CMC documentation for submissions as agreed with the Global Regulatory CMC Scientist Small Molecules, 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, TO Practice Teams, PVU through the PVU GRL as agreed with Global Regulatory CMC Scientist Small Molecules.
For this position, you’ll need the following education, experience and skills:
- Bachelor’s degree required. Master’s degree preferred.
- 5+ years of 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 authorizations 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)
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