Regulatory CMC Senior Manager (100% Position) (m/f)

- Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
- Proactively communicate CMC regulatory strategy, key issues and any other critical topics
- Lead and implement all global CMC submission activities. Make quality regulatory decisions, balancing risks and benefits
- As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions
- Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
- Establish and maintain a single point of contact with FDA or CPOs, DRA re-gional and TA groups for all communication on development and marketed product
- Initiate and lead Health Authority interactions and negotiations
- Lead and drive cross-functional CMC Health Authority Response Teams (HARTs)
- Lead, prepare and communicate CMC dossier risk analyses (SWOTS)
- Keep knowledge up to date with regard to regulatory guidelines and re-quirements
- Represent REG CMC at Global Supply Support Teams (SST), Regulatory re-view boards and other teams and boards as appropriate

- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Strong experience in regulatory and/or experience in drug/biopharmaceuticals
- Fluent English required (oral and written)
- German nice to have
- Experience in regulatory submission and approval processes for new chemical entities (NCE)
- Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects
- Regularly demonstrated active contributions to line functions or project teams, matrix teams
- Demonstrated ability for strategic thinking and risk assessment and mitigation
- Experience with multinational project teams and coordinate activities simultaneously on multiple projects
- Effective planning, organizational and interpersonal skills
- Computer literacy

Weitere Qualifikationen: Regulatory affairs manager