Regulatory Science Team Lead, Raleigh, NC

UCB•Raleigh, NC

9d•$184,000 - $310,000•Hybrid

About The Position

The Regulatory Science Team Lead (RSTL) is a highly driven and seasoned proactive leader with line, as well as matrix management experience. They oversee and guide all regulatory, strategic, and operational activities related to product development and marketing authorizations for UCB products in their teams. Additionally, the RSTL is the primary contact point within UCB for any regulatory issues for their products in the region and, as needed, is a liaison with designated health authorities (primarily FDA).

Requirements

Bachelor’s Degree
Minimum of 10 years of pharmaceutical experience in Regulatory Affairs working with cross-functional and international teams and with knowledge and experience of regional regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension, or license maintenance.

Nice To Haves

Experience with FDA Risk Evaluation and Mitigation Strategies (REMS) preferred.
Demonstrated experience facilitating and coordinating teams and processes with appropriate use of interpersonal skills.
Experience in both leading and training how to lead consultations (formal and informal) with Regulatory Agencies
Experience building effective partnerships - identifies opportunities and takes actions to build effective relationships within the team and with other areas.
Well-versed with influencing skills - through well-thought-through rationale and effective communication skills, able to influence key decisions.
Communication skills - knowing when and how to communicate, using strong interpersonal skills and written communications when appropriate.
Demonstrated ability to leverage AI and digital technologies to optimize internal workstreams and enhance the efficiency, quality, and consistency of regulatory application preparation, submission, and review.
Sensitivity to the diverse cultures comprising the international and global environment.

Responsibilities

Coach and mentor team members and provide guidance and development opportunities.
Serve as the primary regional point of contact for GRL Team leads, COE leads, regional commercial, medical and market access (mission) leads.
Responsible for consultation strategy with Regulatory Agencies as well as preparation for, and execution of, such interactions. Also responsible for training reports and product team members on best practices for such consultations (e.g., formal meetings with the FDA).
Ensure that the regional regulatory strategy for assigned products has been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified, mitigated, and appropriately communicated.
Responsible for ensuring that the regional regulatory strategies, risks and mitigations, and overall plans are effectively discussed with, endorsed by, and communicated to the GRL, GRA regional head, GRA LT, and other functions and affiliates as needed.
Works with Head of US Regulatory Affairs and other RSTLs in the region (and globally) to drive development of regulatory standards, consistent and efficient processes, and SOPs.
Support awareness of UCB and competitors’ activities for relevant products in the region and share the potential impact these activities may have on the product development program.
Maintains awareness of external regulatory environment, new guidelines, and legislation. Participate in trade associations’ activities and working groups as needed and assigned, in line with the UCB portfolio strategy.
Participates, as needed, in overarching GRA or UCB initiatives leading to strategic improvements and operational efficiencies.
Ensures consistent input into GRA assets budget for the region (FTEs assigned products) and works closely with GRL Team leads and CMC&D CoE leads, to ensure alignment, especially before important governance meetings.