Associate Director, Regulatory Affairs CMC and Digital Transformation - Basking Ridge, NJ
1 month ago
Job summary
The Associate Director RACMC is responsible for the regulatory CMC activities from early development to post-approval phase for biological cell and gene therapy small molecule vaccines and/or siRNA drug projects consistent with the company goals Participate on G RACMC teams and support or lead on Component teams andor serve as G RACMC lead or regional submission lead Provide regulatory guidance and strategy to CMC sub team and G RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority HA submission HA meetingsand responses to HA queries Support company goals to building filing strategies that lead to efficient submission timeline approvals in assigned region.
Job description
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
Access all high-level positions and get the job of your dreams.
Similar jobs
Associate Director, Regulatory Affairs CMC and Digital Transformation
Only for registered members
The Associate Director is responsible for regulatory CMC activities from early development to post-approval phase. · Organize and manage the preparation of submissions to Health Authorities. · Coodinate activites required for timely and accurate reporting of information to existi ...
1 month ago
We are looking for a forward-thinking Digital Transformation Manager to help reshape how our business works: one workflow, one system, and one strategic initiative at a time. · We're more than a flooring company. · We're a growing, collaborative community grounded in four core va ...
5 days ago
We are recruiting a Digital Transformation Lead in New York for our partner network. · Translate digital strategy into actionable transformation roadmaps and implementation plans · Own end-to-end delivery of digital transformation programs, from ideation through execution and cha ...
1 month ago
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Digital Transformation Manager. · ...
4 days ago
This position is key in leading Digital Transformation initiatives that modernize processes, data and tools. · ...
4 days ago
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Digital Transformation Manager. · ...
3 days ago
+Baker Tilly is an advisory firm looking for an entrepreneurially-minded Principal to lead their Digital Transformation Practice. · +Mentor and coach staff in digital transformation projects. · Develop business development objectives to grow the Baker Tilly Digital business lines ...
1 month ago
We are looking for a Digital Transformation Manager to help reshape how our business works: one workflow, one system, and one strategic initiative at a time. · Building and maintaining a 1-2 year digital transformation roadmap aligned to ACS's operational and strategic goals. · I ...
4 days ago
Baker Tilly has an incredible opportunity for a Principal to join its Digital Transformation Practice. · Advance Business Development objectives · Lead transformation projects · ...
1 month ago
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Digital Transformation Manager. · This role is vital in leading Digital Transformation initiatives that modernize processes, data, and tools. · Your leadership will significantly i ...
4 days ago
We're looking for an experienced Digital Transformation Lead to join our Technology team at Point72. As a key member of our team, you will oversee planning, execution and delivery for infrastructure-focused digital transformation projects. · ...
1 month ago
We are one of the fastest growing IT Consulting company across the USA and we are hiring Digital Transformation Leader for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various ve ...
2 weeks ago
We're a team of experts experimenting discovering new ways to harness the power of open-source solutions embracing enterprise agile methodology we encourage professional development ensuring you bring innovative ideas our products satisfying your own intellectual curiosity. · ...
1 month ago
We're constantly improving our company's IT infrastructure, positioning us at the forefront of a rapidly evolving technology landscape. We encourage professional development to ensure you bring innovative ideas to our products while satisfying your own intellectual curiosity. · ...
6 days ago
We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. · ...
1 week ago
+The Senior Vice President, Sales – Experience Transformation is a senior individual-contributor growth leader responsible for originating, shaping, and closing complex enterprise transformation engagements. · +Identify and pursue new leads that have the potential to grow into mi ...
1 month ago
A global Japanese company seeks a Digital Transformation Program Lead to oversee technology-driven initiatives. · Manage cross-functional projects · ...
1 week ago
The Senior Vice President, · Sales – Experience Transformation is a senior individual-contributor growth leader responsible for originating and shaping complex enterprise transformation engagements. · This role focuses on selling high-impact digital transformation,customer experi ...
1 month ago
We're seeking a Digital Transformation Product Lead to partner with clients and internal teams to deliver end-to-end implementation of Broadridge's digital compensation solutions.Acting as the bridge between business and technology, the Product Lead drives digital enablement, pro ...
1 month ago
We're seeking a Digital Transformation Product Lead to partner with clients and internal teams to deliver end-to-end implementation of Broadridge's digital compensation solutions. · ...
4 days ago