Regulatory Affairs Senior Manager, Intercontinental (ICO)
- Managing and executing successful regulatory strategies in cooperation and alignment with Commercial Operations throughout the product lifecycle in the allocated countries/ markets within ICO.
- Leading regional regulatory team
- Supporting local/ regional regulatory team members in: obtaining and maintaining registration of allocated products; establishing and maintaining effective working relationships with the relevant key external & internal stakeholders.
- Collecting regional and local regulatory statues and guidance in order to provide relevant, high quality and strategic regulatory advice to project teams and allocated development and established products.
- Supporting the Regional ANI in developing comprehensive and commercially-aligned regulatory strategies to the CSLB’s business.- Develop basic knowledge of the dossiers for all the products registered
- Collecting and providing requirements for obtaining/ maintaining registration to the relevant Global Regulatory Lead (GRL), product specialists and GRA stakeholders.
- Responsible for a specific submission package (new product/indication submission, variations, renewal) in the region, support for tenders and for the planning and preparation of the modules 2-5 by the GRL/product specialist, review modules 2-5. Be responsible for the strategy, preparation, planning and coordination of module 1 elements; submission and tracking of submission package.
- Responsible for the overall coordination and dispatch of responses to HAs questions. Support the GRL/product specialist for the strategy, planning and preparation of response for complex scientific questions requiring product expertise and contacting internal stakeholders. Responsible for preparing answers for simple questions not requiring product expertize or input from other internal stakeholders.
- Supporting regulatory staff so that high quality working relationships are established and/or maintained with the relevant agencies and distributors/ MAH to support negotiation with HA to ensure positive outcomes for CSL.
- Forwarding to Global Labeling and answering any requested deviation to the Core Company Data Sheet.
- Representing GRA in selected Global Regulatory Affairs Strategy Teams (GRAST). As representative, responsible for collecting/ consolidating/ proposing/ aligning feedback from markets to produce a country/regional regulatory strategy and cascade GRAST decisions and information.
- Building and maintaining relationships within Global Regulatory Affairs; to provide regulatory support to Commercial Operation team in achieving business objectives.
- Ensuring high quality, complete initial submission in line with corporate objectives; managing major and minor applications to meet business objectives and timelines with competitive outcomes. Ensure and monitor local registration activities including supporting the development of processes to ensure efficient and timely registration of new products and maintenance of existing products.
- Ensuring the timely and efficient identification of regulatory risks associated with the products and issues relating to emerging regulatory environment changes in the markets to senior management.
- Supporting on-boarding of new hires and continue self-development. Actively contribute to the global CSL regulatory community through designated projects (meetings, trainings, workshops etc.)
- BSc/MSc degree or equivalent in life science, pharmacy, medical laboratory technology, or other health/medical related area. (Other degrees and certifications considered if commensurate with related quality management, regulatory or clinical research experience.)
- Experience in leading and managing a global team of professional staff.
- Regulatory experience in the biotechnology sector and/or plasma products of 5 years or more is desired.
- Excellent written and oral communication skills in English and German.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
- Experience in facilitating resolution of issues with local regulatory agencies with positive outcomes.
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