Ensure regulatory conformance and consistency globally in compliance with external regulatory requirements and internal policies
Job description
Responsibilities
•Demonstrate knowledge of global CMC regulatory requirements and criteria for submission and approval
•Drive resolution of critical issues while applying balanced judgment to drive crisp decision-making
•Cultivate relationships with key partners and stakeholders, including R&D, Quality, Local and Regional Regulatory Lines etc., to ensure alignment on regulatory strategy and serve as a technical resource
•Prepare and deliver high-quality CMC regulatory submissions anticipating contemporary assessor thinking for new registrations, post approval changes, renewals, annual reports, line extensions and queries from Regulatory Authorities according to global filing requirements with some guidance
•Ensure the integrity of regulatory CMC submissions including review of supporting technical documentation and associated investigations with minimal oversight
•Drive timely completion of CMC commitments made to regulatory authorities
•Ensure regulatory conformance and consistency globally in compliance with external regulatory requirements and internal policies, standards, and procedures
•Execute using established operational processes for delivering the product portfolio
•Display accountability for delivery of assigned portfolio
•Prioritize and complete assigned workload, including delivery on submission plans in accordance with timelines for specific projects/products/markets with limited supervision
•Serve as CMC representative on a core project and manage project activities
•Mentor colleagues within focused area of expertise and share experiences with the team
•Contribute to CMC-related projects, initiatives & actions, and maintain compliance with internal training requirements and policies, modeling adherence to client behaviors, values and Principles of Integrity
Qualifications
•Minimum of a Bachelor's Degree in Science or related discipline Minimum of 6 years relevant pharmaceutical experience
•A combination of experience and education may be taken into consideration
•Must include a minimum of 2 years of hands-on CMC authoring experience (initial registrations or post-approval variations)
•Demonstrated knowledge of pharmaceutical development, commercial lifecycle management and associated cGMP requirements relevant to the assessment of technical and regulatory merits of data needed to support CMC changes and commitments
•Advanced degree (MS/MSc, PhD, PharmD) Emerging awareness of new scientific or manufacturing technology
•Advanced skills in written & oral communications Computer literacy with Microsoft Office Suite and Documentum-based applications.
