Director – Regulatory Operations
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Job Description
Director or Associate Director of Regulatory Operations for Red Nucleus, specializing in client deliverables and business process optimization.
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
- 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.
Requirements:
- 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.
Benefits:
- Flexible work arrangements
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