About This Role

This role is responsible for regional regulatory expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific small molecule, oligonucleotide, biologics projects and/or devices, working with CMC Global Regulatory Lead and key stakeholders, primary contact for affiliates on regulatory CMC activities in the assigned regions and managing of routine and non-routine regional Health Authority interactions as delegated by the CMC global regulatory lead. 

What You’ll Do

• Provide regional strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
• Preparation and delivery of CMC regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions.
• Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities in assigned regions.
• Write and / or Review of regional and global CMC submission documents and responses to Health Authority questions
• Manage CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
• Monitor changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams.
• Provide input into regulatory CMC risks assessment and mitigation plans from a regional perspective for assigned regions and ensure that it remains in line with the overall global regulatory CMC strategy.
• Coordinate and completing regulatory assessments of CMC changes in the designated systems 
• Responsible for assuming responsibilities from the global regulatory lead, as agreed and delegated and maintaining open lines of communication with the lead on assigned projects/products to ensure awareness on status and issues relating to regional submissions.
• Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of RegCMC on cross functional work streams

Who You Are

You are an enthusiast team-worker, passionate about motivating people to be the best they can be, working inclusively, collaboratively, effectively and efficiently with others internally and externally. You are able to create strong, productive working relationships in a global setting with many different cultures.

Required Skills

• BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
• 5+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in global Regulatory CMC 
• Successful authoring and contribution to delivering CMC submission documents of development and marketed products (biological, oligonucleotide, and/or chemical entities)
• Recognized experience in project and timeline management
• Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively(strong ability to lead without authority)

The CMC RRL is primary contact for affiliates on regulatory CMC activities in the assigned region (i.e. United States, Canada, Latin and South America where located in the United States)

All your information will be kept confidential according to EEO guidelines.