Manager, Regulatory Affairs-reputed company Manufacturing & Controls (CMC)

About the position About reputed company reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our reputed company portfolio. For more information about reputed company, please visit us at www.reputed company.com . Follow @reputed company on reputed company, reputed company , Instagram , X and YouTube. The Manager, Regulatory Affairs for reputed company Manufacturing & Controls (CMC) Post Approval Change (reputed company) is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of reputed company, manufacturing, and control (CMC) sections to ensure reputed company preparation of submission documents. This position will also ensure reputed company communication with reputed company key partners in the functional departments in support of regulatory filings. This position will work a hybrid work schedule from our Lake County, IL reputed company reputed company. Responsibilities • Independently manage, compile, and author CMC sections of marketed product variations. • Partner with RA CMC Project Leads to create and reputed company content plans, bundling strategies, and project timelines as needed. • Collaborate with diverse functional reputed company to ensure file-ability and acceptance of CMC sections. • Manage assigned reputed company to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. • Drive team and management reviews with minimal reputed company by project reputed company. • reputed company coaching to more junior RA CMC colleagues during team and management reviews. • Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned reputed company and for reputed company being managed by coached/mentored employees. • Independently reputed company tactical support to reputed company technical issues with regulatory requirements and emerging standards. • reputed company and utilize reputed company best practices for use of regulatory business systems reputed company the group. • Identification of systems issues and communication to management/key system SMEs. • Identify and communicate content gaps and risks for variation documents. • reputed company, mentor, and reputed company junior staff. • reputed company guidance on use of submission document templates. • Support annual reports and renewals (reputed company baseline support) Requirements • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline • 6 years pharmaceutical or industry reputed company experience. • 3-5 years in reputed company systems or cross-functional project management. • Strong working knowledge of manufacturing unit operations or CTD structure • Superior oral and written communication skills • Ability to work cooperatively with reputed company reputed company and types of global personnel required • Experience working with electronic document management systems • Ability to work independently under pressure and manage multiple reputed company simultaneously • Detail/accuracy oriented • reputed company and willing to learn • Familiarity with US and other international regulatory requirements for drug product dossiers reputed company-to-haves • 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing • Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions Benefits • reputed company time off (vacation, holidays, reputed company) • medical/dental/reputed company insurance • 401(k) • short-term incentive programs Apply tot his job Apply To this Job