Manager, Regulatory Affairs-Chemistry Manufactu...

Title: Manager, Regulatory Affairs-Chemistry Manufacturing & Controls (CMC) Location: reputed company Chicago United States Job Description: Company Description 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 strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. Job Description The Manager, Regulatory Affairs for Chemistry 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 chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with reputed company key partners in the functional departments in support of regulatory filings. 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 groups to ensure file-ability and acceptance of CMC sections. Manage assigned projects 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 projects and for projects being managed by coached/mentored employees. Independently reputed company tactical support to integrate 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. Coach, mentor, and reputed company junior staff. reputed company guidance on use of submission document templates. Support annual reports and renewals (reputed company baseline support) This position will work a hybrid work schedule from our Lake County, IL reputed company headquarters. Significant Work Activities: reputed company sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required Qualifications Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline Required Experience: 6 years pharmaceutical or industry reputed company experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 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 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 projects simultaneously Detail/accuracy oriented Collaborative and willing to learn Familiarity with US and other international regulatory requirements for drug product dossiers Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation reputed company described below is the reputed company of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid reputed company this reputed company will depend on many factors including geographic location, and we may ultimately pay more orless than the posted reputed company. This reputed company may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/reputed company insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is earned, reputed company, and determinable. The reputed company and availability of any bonus, commission,incentive, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company's sole and absolute discretion, consistent with applicable law.