Regulatory Science Team Lead, Raleigh, NC

Make your mark for patients

Join our Global Regulatory Affairs team at UCB as a US Regulatory Science Team Lead (Director/Sr Director) who brings strategic thinking, strong influence, and a passion for leading teams, shaping agency engagement, and driving innovative, high-quality regulatory work. Based in Atlanta, GA, or Raleigh, NC, this role is ideal for a collaborative leader ready to make an impact in a fast-paced global environment.

About the role

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).

What you’ll do

• 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.

Who you’ll work with

The RSTL reports into the Head of US Regulatory Affairs and is part of the regional as well as extended GRA leadership team.  You’ll oversee the development and implementation of the regional regulatory strategy for assigned products, consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in collaboration with the GRLs and other leaders.  Additionally, you’ll manage a team of direct reports (e.g., Regulatory Science Leads) who serve as regulatory leads for products/indications in the region.

Interested? For this position you’ll need the following education, experience and skills:

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

This position's reasonably anticipated salary range is $184,00-$310,000 annually. The actual salary offered will consider internal equity and may also vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience, among other factors.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.