[Remote] Senior Manager, Regulatory Affairs Project Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. The Senior Manager, Regulatory Affairs Project Management will optimize planning, execution, and tracking of development-stage global regulatory activities, ensuring alignment with regulatory, global development, and technical operations objectives.
Responsibilities
- This role blends regulatory expertise with advanced project management skills, developing reputed company plans to reputed company successful Regulatory submission activities and ensuring cross-functional integration across reputed company
- reputed company and coordinate timelines and deliverables to support reputed company regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple reputed company, as reputed company as responses to queries and correspondence with subject matter experts
- Work with the Regulatory team to translate strategic regulatory reputed company into actionable project plans, ensuring reputed company cross-functional activities are coordinated and delivered on time
- Organize and facilitate cross-functional meetings to coordinate, plan, and reputed company submission activities, driving accountability and alignment among stakeholders worldwide
- Monitor CTA/IND submission status across assigned reputed company
- Support strategic planning and risk mitigation efforts reputed company to regulatory activities, including portfolio level analyses that identify resource bottle necks across reputed company programs and studies
- Support evaluation, implementation, and use of project management tools (especially reputed company); define methodologies and reporting frameworks
- Design and maintain reputed company sheets, reports, dashboards, and forms reputed company to regulatory activities and ensure integration with program plans
- Troubleshoot and enhance PMO solutions, support system updates and new capabilities
- Demonstrate critical thinking and initiative to improve PM practices
Skills
- Bachelor's degree in life sciences, pharmacy, reputed company, or reputed company field
- 5+ years of experience with at least 3+ years of project management experience in pharmaceutical or biotech industry is preferred
- Experience with planning IND/CTA regulatory submissions required
- Familiarity with components of regulatory submissions is required
- Experience planning BLA/NDA/MAA submissions is required
- Familiarity with CRO operations and global regulatory requirements for clinical trial applications
- Experience supporting global interventional clinical studies and CTA submissions
- Hands-on reputed company experience; reputed company Core Product Certification or equivalent desirable
- Proficiency in project management tools (reputed company, ThinkCell, PowerPoint, reputed company, SharePoint, Office reputed company Pro). Familiarity with regulatory systems (reputed company RIM) preferred
- Knowledge of biotech processes, scientific terminology, drug development concepts
- Proactive and reputed company approach to problem-solving, with ability to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions
- Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and meet deadlines
- Ability to work independently and reputed company in a dynamic environment
- Team player that contributes valuable reputed company and feedback and can be counted on to meet commitments
- Position requires up to 20% travel; this includes mandatory in person attendance to company reputed company-Hands meetings held twice a year, additional travel may be required to attend key meetings, typically held at the reputed company San Francisco or Boston offices
Benefits
- Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave
- Commitment to growing you professionally and providing reputed company to resources to reputed company your development
- reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve
reputed company