Are you a highly organized and detail-oriented individual with a passion for project management? Do you have experience in the pharmaceutical industry and a deep understanding of CMC regulations? If so, we have an exciting opportunity for you to join our team as a GRA CMC Lead at Sanofi. In this role, you will be responsible for leading and managing CMC submissions for our global regulatory affairs team. We are looking for someone who is a strong communicator, able to work in a fast-paced environment, and has a strong understanding of global regulatory guidelines. If this sounds like you, we would love to hear from you.
- Lead and manage CMC submissions for global regulatory affairs team.
- Ensure all CMC submissions meet regulatory requirements and timelines.
- Keep up-to-date with CMC regulations and guidelines in various regions.
- Communicate effectively with internal teams and external stakeholders regarding CMC submissions.
- Develop and maintain project timelines for CMC submissions.
- Manage project budgets and resources.
- Conduct risk assessments and develop contingency plans for potential submission issues.
- Coordinate with cross-functional teams to gather necessary information for CMC submissions.
- Review and approve CMC documentation for accuracy and completeness.
- Maintain a high level of organization and attention to detail throughout the submission process.
- Communicate any changes or updates to CMC regulations to the global regulatory affairs team.
- Provide guidance and training to team members on CMC regulations and submission processes.
- Ensure compliance with company policies and procedures related to CMC submissions.
- Stay informed about industry trends and updates in CMC regulations.
- Represent the company at regulatory meetings and conferences related to CMC submissions.
- Collaborate with other departments, such as quality assurance and manufacturing, to ensure alignment on CMC submissions.
Advanced Degree In Pharmaceutical Sciences Or Related Field: A Gra Cmc Lead Should Have A Strong Foundation In Pharmaceutical Sciences And Possess An Advanced Degree In The Field. This Will Enable The Individual To Understand The Complexities Of Drug Development And Regulatory Requirements.
Extensive Experience In Regulatory Affairs: The Gra Cmc Lead Should Have A Minimum Of 8-10 Years Of Experience In Regulatory Affairs, With A Focus On Cmc. This Experience Should Include Interactions With Regulatory Agencies And Involvement In The Submission And Approval Of Cmc-Related Documents.
Comprehensive Knowledge Of Cmc Regulations: The Individual Should Have An In-Depth Understanding Of Cmc Regulations And Guidelines, Including Ich, Fda, And Ema Requirements. This Knowledge Is Critical In Ensuring Compliance And Successful Submissions.
Strong Project Management Skills: As A Gra Cmc Lead, The Individual Will Be Responsible For Managing Multiple Projects Simultaneously. Therefore, They Should Possess Excellent Project Management Skills, Including The Ability To Prioritize Tasks, Meet Timelines, And Communicate Effectively With Cross-Functional Teams.
Leadership And Team Management Experience: The Gra Cmc Lead Will Be Responsible For Leading A Team Of Regulatory Professionals. Therefore, The Individual Should Have Prior Experience In Team Management And Possess Strong Leadership Skills To Motivate And Guide The Team Towards Achieving Common Goals.
Quality Assurance
Change Management
Strategic Planning
Project Management
Vendor Management
Data Analysis
Communication
Time Management
Team Leadership
Problem-Solving
Resource allocation
Cross-Functional Collaboration
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a GRA CMC Lead is $75,000-$100,000 per year. This can vary depending on factors such as location, experience, and specific job responsibilities. Some companies may also offer bonuses or other benefits in addition to the base salary.
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Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.
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