Regulatory Affairs Temp - Associate Manager, Regulatory Project Management - Hybrid Tarrytown, NY (3-4x onsite per week) Tarrytown, New York

Orbis Clinical is seeking a Temp – Associate Manager, Regulatory Project Management located in Tarrytown, NY (Hybrid 3-4x onsite per week) for 6 months.

Job Title: Temp – Associate Manager, Regulatory Project Management

Location: Tarrytown, NY (Hybrid 3-4x onsite per week)

Contract: 6 months

Build our future together:

We use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Temporary – Associate Manager to join our Regulatory Project Management team. This role is responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (IPA) to post-marketing. May serve as the Reg PM lead for assigned therapeutic area (TA) and ensure success for regulatory programs under that TA. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Discover your role:

• Partners with Regulatory Affairs in driving program team to successfully meet regulatory milestones
• Facilitates Global Regulatory Sub-team meetings with Regulatory Affairs liaison as the meeting chair
• Conducts working group meetings to monitor and track progress of major submissions
• Conducts kickoff meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations
• Reviews regulatory portfolio slides for complete and accurate milestones dates to help prepare for cross-functional and upper-management discussions
• Creates submission timelines and responsibility matrices through cross-functional discussions
• Maintains accurate program timelines for cross-reporting with other functional groups
• Communicates program projections and progress and serves as the key contact for coordinating regulatory activities and milestones
• Provides guidance to team members and cross-functional groups to resolve issues related to timelines, submission documents or other regulatory-related matters that could impact the timeliness or quality of submissions
• May provide oversight of therapeutic area(s) by guiding other team members who are responsible for project managing regulatory milestones such as pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports

This role requires:

• Bachelor’s Degree
• 5+ years of industry and/or relevant experience
• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• Requires eCTD knowledge.
• Microsoft Project skills required
• Project management skills desired.
• Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of electronic document management systems (eg, SharePoint) is desirable.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $50.00 – $65.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.