Manager – Global Regulatory Affairs – CMC – Vaccines

Manager – Global Regulatory Affairs – CMC – Vaccines

Requirements

• Earned Bachelor’s degree in a relevant discipline required, Masters degree preferred
• 4+ years of pharmaceutical industry experience, ideally in manufacturing, quality assurance or quality control
• 4+ years CMC regulatory experience
• Experience with preparation & management of filings; ensuring thoroughness, accuracy, timeliness of CMC dossiers & responses
• Experience responding to Health Authority comments and issues related to submissions
• Experience working in a matrix environment and excellent people skills are required
• Strong organization skills
• Concise, informative and persuasive communication skills to impact project teams and HA interactions
• Strong Regulatory knowledge and demonstrated application of requirements is very helpful
• Strong background in drug development, manufacturing, or testing
• Proficient in MS Word, Excel, PowerPoint
• Demonstrated ability to work successfully on global project teams.

Responsibilities

• Develops the regulatory CMC strategy for the project(s)/product(s) assigned
• Compiling all the relevant information necessary to support the best regulatory CMC strategy for registration of a new vaccine or a license update in all concerned countries
• Developing and maintaining the Regulatory CMC Strategy Document (GCRSD) when applicable and keeping the document updated throughout the life of the project/product
• Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions
• Contributing to the Global Regulatory Product Strategy (GRPS) as requested via the GRT and/or GRTL
• Participating and performing change control assessment (CCRs) (for major markets) of any necessary changes proposed by IA and preparing the RSID and implementation plan with a global view for the impacted product(s)
• Responsible for Modules 2 and 3 of the CTD for applicable marketing applications, related amendments or variations and all routine license maintenance activities
• Providing support for all applicable products in all phases of development
• Coordinates the creation of the module 2.3 and module 3 Common Technical Documents (CTD) for License Applications
• Executes and implements the defined regulatory strategy and/or GCRSD via relevant CMC submissions
• Prepares and coordinates the creation of the CMC documents in support of complete license applications (CTD, IND, BLA, etc.) and other regulatory submissions for regulatory authorities and/or third parties
• Authors CMC related documents/summaries, coordinates reviews and approvals, and provides editorial review for all CMC components of regulatory applications and submissions
• Ensures preparation of the CMC components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions
• Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions
• Independently responsible for reporting on progress and specific issues pertaining to project/product CMC responsibilities
• Communication should be proactive and timely
• Work jointly with GBU / Global Regulatory Team Leads (GRTLs) / Subject Matter Experts for the planning and coordination of regulatory CMC activities relating to projects/products from initiation to approval
• Developing CMC related regulatory objectives and target dates
• Providing timelines for critical CMC regulatory activities to be incorporated into the project plan
• Responsible for the notification / communication to the most appropriate individuals within the company based upon the topic criticality of the issues to be addressed
• Discusses and negotiates issues with regulatory authorities/third parties; and communicates, documents and archives information for the organization
• Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority
• Sets up the necessary meetings with regulatory authorities/third parties and co-ordinates the preparation of the pre-reads and the presentations, in connection with the GRT
• Responsible for timely and accurate tracking of CMC related regulatory authority requests and commitments and to manage completion
• Participate and provide support in all applicable inspection preparation activities and inspections, as requested
• Provide project/product-related input and resources towards the development and implementation of new RA systems, procedures, and/or tools
• Responsible for providing regulatory CMC advice and guidance to Project/Product Team members and other functional areas on regulatory matters

Preferred Qualifications

• Foundational understanding of Artificial Intelligence and impact on industry is highly preferred