Are you poised to elevate your career to the next level? Have you been seeking an opportunity where your hard-earned skills, rich experience, and heartfelt passion can truly make a difference? We invite you to bring your best self into a role that allows you to contribute meaningfully while collaborating with a team of innovative and driven professionals. Join us in our quest to impact lives on a global scale, as we strive towards being at the forefront of the biotechnology industry, making a difference in the lives of over 10 million patients worldwide.
The Role: Global Submission Management - Manager
In this pivotal role, you will be the linchpin ensuring the seamless and compliant exchange of information across various functions both within and external to our Global Regulatory Affairs and Safety (GRAAS) team. This includes liaising with local offices, external partners, and regulatory authorities. Your strategic technical expertise will be crucial in driving operational excellence, fostering innovation, and ensuring the technical compliance of our global regulatory submissions.
Responsibilities
Oversee and guide the functional areas of the department as well as outsourced resources.
Establish and enforce procedures for the meticulous processing of both incoming and outgoing regulatory documentation, focusing on publishing perspectives.
Offer strategic advice to global cross-functional teams on dossier deployment strategies, submission timeline development, and the structuring of regional dossiers.
Act as the department's representative on global initiatives, bringing forth your expertise.
Spearhead process development and improvements, ensuring the department stays at the cutting edge of regulatory compliance and efficiency.
Lead projects related to information systems and software updates, including system validations.
Compile and present publishing metrics to senior management, offering insights and recommendations.
Provide unwavering technical support for regulatory systems.
Your Expertise
Demonstrated experience in leading teams with a collaborative spirit.
In-depth understanding of the regulatory operations landscape, including business principles.
Proficiency in global Clinical Trial and Marketing Applications regulations and guidance.
Strong project management skills, especially in regulatory-focused projects.
Expertise in eCTD, eCTD specifications, and associated software.
Comprehensive knowledge of International Clinical Trial submission requirements, country-specific regulations, and relevant software tools.
Qualifications
Doctorate degree, or
Master's degree + 3 years of directly related experience, or
Bachelor's degree + 5 years of directly related experience, or
Associate degree + 10 years of directly related experience, or
High school diploma/GED + 12 years of directly related experience.
Preferred Experience
A background in regulatory operations-focused roles.
Experience in engaging with global regulatory authorities regarding submissions.
Advanced knowledge in regional agency requirements for submissions.
Proficiency with standard software used in regulatory publishing.
Why Join Us?
We are deeply committed to the professional and personal growth of our team members. Our Total Rewards Plan is designed to take care of you, offering:
A comprehensive benefits package, including retirement savings plans with significant company contributions, health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
Generous time-off plans, including bi-annual company-wide shutdowns.
Flexible work models, including remote work opportunities where possible.
Ready to Make an Impact?
If you're looking for a career that challenges and inspires you, consider joining our mission. We're closer than you think to the next big step in your career. Apply now and let's make a difference together.
Employment Type: Full-Time
Salary: $ 77,000.00 Per Year
