Job Description

Core Job Responsibilities: - Provide strategic input into the development of regulatory submissions and timelines for assigned products/projects, seeking guidance where appropriate. - Provide input into international regulatory submission plans as ap

Core Job Responsibilities: - Provide strategic input into the development of regulatory submissions and timelines for assigned products/projects, seeking guidance where appropriate. - Provide input into international regulatory submission plans as appropriate. - Attend and actively participate in regulatory sub-team meetings that include representatives from different international locations. - Monitor actual vs. planned activities and timelines and identify issues impacting project progression. - Assist with the preparation and review of technical regulatory documentation for agency submission. - Ensure the accuracy and quality of documentation included in regulatory submissions. With Manager Oversight and Supervision: 1. Product registrations /Submissions - Prepare CMC registration packages to support new registrations, post approval changes, and renewals - Identify and collect required data - Seek expert advice and technical support to complete packages - Prepare responses to deficiency letters 2. Relationships & Cross Functional team work - Represent Regulatory Affairs at relevant meetings and present agreed RA CMC position - Build and maintain relationships within CMC group and one-on-one relationships with relevant counterparts such as Global and Regional Product Leads, MS&T, Qualityand drug product development - Monitor actual vs. planned activities and timelines - Identify and communicate issues impacting project progression 3. Compliance across Life-Cycle - Assess and approve manufacturing change requests and update files accordingly (may not be applicable to all staff) - Maintain awareness of legislation and current developments within specific area of business - Work to assure products remain in compliance 4. Strategy With manager oversight, for complex projects or independently for routine projects:- - Develop regulatory product CMC strategies - Identify risks and elevate them along with possible remediation 5. Process Improvement - Independently identify opportunities and suggest improvements for resolution - With oversight, lead the development of position papers & work aids etc. Travel: Up to 25% may be required JOB SPECIFICATIONS: Skill, Education, Experience Minimum Education: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology or related subject. Diploma in Regulatory Affairs is preferred. Minimum Experience / Training Required: - Excellent oral and written technical skills - Excellent command over spoken and written English is mandatory - Strong interpersonal skills to work effectively with global teams is critical - Attentive to detail - Ideally, 5-7 years work experience in the pharmaceutical industry such as R&D, Quality, Product development - Preferred experience in Global Regulatory filings, submission of registration dossiers and post-approval variations - Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and Power Point)