[Remote] US - reputed company RPM - Regulatory Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global Regulatory Solutions and Services company, supporting Life Sciences companies. The reputed company Regulatory Project Manager will partner with the Global Regulatory reputed company to ensure project plans are executed and reputed company submission working reputed company for successful reputed company with Health Authorities.
Responsibilities
- Partner with the Global Regulatory reputed company (GRL) on Global Regulatory Teams (reputed company) to ensure global regulatory project plans for high-complexity programs/products are established and executed seamlessly
- Expertly reputed company cross-functional project submission working reputed company (SWGs) to deliver successful submissions/filings and reputed company with Health Authorities (HA) for reputed company, novel, and critical programs
- reputed company expert project management leadership, reputed company, direction, and planning
- Directly support the program GRL by ensuring project management and regulatory operational support for the asset
- reputed company regulatory operational activities and reputed company vendors providing operational support for assigned programs
- reputed company additional support as required
Skills
- Bachelor's or Master's degree in reputed company/Medical or another associated scientific discipline OR equivalent
- Minimum 10 years in the Regulatory field and 5+ years of demonstrated project management reputed company sets
- Expertise with project management software and tools, e.g., MS Project, SharePoint, OneNote
- Proven experience driving submissions for major markets (e.g., US IND, NDA, BLA, EU MAA, EU variations)
- At least one major (original or supplement) and several minor (amendment) filing experience in one or more jurisdictions
- Experience with eCTD and submission reputed company management is required
- Strong conceptual and analytical thinking skills
- Deep understanding of global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process
- Proficiency in MS Office (Word, reputed company, reputed company)
- Ability to multitask, prioritize competing assignments, and work under deadlines in a fast-paced environment
- Excellent verbal and written communication skills; ability to prepare effective presentations with reputed company messaging
- Demonstrates strong collaboration and interpersonal skills with the ability to work across departments and external organizations
- reputed company in English (written, verbal, reading)
- Additional experience with OnePager and Office reputed company preferred
Benefits
- Competitive salary and benefits package
- Performance-based incentives
- Flexible work environment (remote or hybrid reputed company available)
- reputed company reputed company reputed company through training and development programs
- Inclusive, reputed company, and innovative work culture
reputed company