Red Nucleus · 4 days ago
Director/ AD Regulatory Operations
United States
Full-time
Remote
Director/Executive
10+ years expRed Nucleus is a premier provider of global solutions for the life sciences industry, and they are seeking a Director or Associate Director of Regulatory Operations. This role involves partnering with internal leadership and clients to ensure deliverables meet expectations, while also contributing to business transformation and coaching junior team members.
E-LearningEducation
Responsibilities
Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information. Project Management across all R&D contributors to global submissions
Project Management across all R&D contributors to global submissions
Collaborate with R&D Operations Extended Leadership Team in overall management of RegOps team and Staff including managing direct reports, training and coaching junior staff
Acts as RegOps business development SME for clients or potential clients (e.g., contracts, negotiations, strategies)
Analyze market trends, evaluate business models, and support clients in areas such as R&D strategy, commercialization, market access, and portfolio optimization
Manage regional submissions and support global submissions as a Lead Publisher
Proactively communicate requirements and issues to be considered to the Submission Team and contribute to achieving realistic timelines
Proactively collect necessary information from the Submission Team and plan all submission management related activities
Lead and support clients in global submissions and assessment and implementation of information, document and labeling management technology
Proactively communicate with clients on submission requirements
Submission management lead for applications at various stages of drug development (pre-IND through marketed products) and across multiple regions (US, Canada, EU) as needed
Liaise with agency experts on electronic submission requirements
Qualification
Required
Bachelor's degree in Life Sciences, Business, or related field required
10+ years of experience in management consulting, life sciences strategy roles, or a relevant field
Strong analytical and problem-solving capabilities
Excellent communication and presentation skills
Polished presentation & moderating skills
Understanding of pharmaceutical and life science industries
Rigorous attention to detail and accuracy
Self-starter and driven
Ability to multi-task with superior organization skills
Strong ability to work independently as well as be an integral part of a team
Dependable and flexible
Excellent written, verbal communication, and time management skills
Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio
Ability to work in a global environment with an understanding of cultural differences and work practices
Preferred
Master's degree
Company
Red Nucleus
Red Nucleus is a professional training company specializing in marketing learning systems and workshops.
501-1000 employees
H1B Sponsorship
Red Nucleus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-17Acquired
Leadership Team
Ian K.
Chief Executive Officer
Breanne Chase
Chief Operating Officer, Med Comms 2
Recent News
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