Senior Regulatory Affairs CMC Manager – Paddington, London (Hybrid)
Anywhere, United Kingdom
G&L
Posted on: July 30, 2024
Closing: August 29, 2024
Position Type: Full Time
Job Description
- Develop and maintain high-quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
- Responsible for global CMC regulatory strategies with a focus on innovation and compliance.
- You will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions that will increase efficiency and minimize timelines.
- Identify the required documentation and any content, quality, and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones.
- Author and review all CMC documentation for global submissions, working to strict deadlines and aligning with our client’s defined regulatory strategies, current regulatory trends, and guidelines.
- Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes. Proactively communicate strategies, risks, and key considerations throughout the life cycle to a variety of other stakeholders.
- Lead, prepare, and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals, and risk mitigation plans. Establish and maintain a single point of contact with FDA.
- Develop and maintain high-quality, realistic, cross-functional plans. The CMC consultant will develop timelines when the synopsis/draft protocol is available.
- Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
- Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
- Responsible for arranging and leading discussions on the clinical study and CMC plans.
- Present clear CMC plan reports to stakeholders.
- Operate within the Governance Board model for communication and accountability.
- Provide continuous improvement on CMC plans and standard MS Project templates.
Requirements
- You should have around 5-10 years of experience in regulatory affairs.
- You will need comprehensive experience in the regulatory submission and approval processes.
- You should have working knowledge of biotechnology and pharmaceutical products.
- All our consultants are expected to have the ability to work independently and work seamlessly with our clients’ project teams.
- You should have excellent planning, organizational, and interpersonal skills, including a good command of the English language.
Apply
G&L
Posted on: July 30, 2024
Closing: August 29, 2024
Position Type: Full Time
Career Focus: Regulatory, Analyst, Regulatory/Compliance
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