.Job DescriptionThe PositionReporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful Associate Principal Scientist will be accountable for assessment of changes for regulatory impact, development of regional CMC strategy in EU/EEMEA, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire company portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.They will work closely with CMC Product Leads to ensure that key CMC projects are successfully prosecuted in the region.Responsibilities:Bring energy, knowledge, innovation, and leadership to carry out the following:For assigned product portfolio, develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.Working collaboratively with Global CMC Regulatory Affairs Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the products life-cycle.Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.Boost Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of life-cycle submissions (as CMC content subject matter expert).Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for EU/EEMEA markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to promote right first-time submissions.Ensure high quality and timely responses to Regulatory Agency questions in EU/EEMEA markets and fulfilment of regulatory commitments to Regulatory Agency deadlines.Sponsor product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business