UCB Anderlecht Belgium
2 weeks ago
Make your mark for patients
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
We are seeking a motivated Regulatory Science Lead to be an integral member of our Global Regulatory Affairs group. This person will:
Be responsible for all regulatory activities related to product development and marketing authorizations within their assigned U.S. region and is the primary contact point within UCB for any regional regulatory issues with the product and with... designated health authorities. Be a line manager, with direct reports, overseeing multiple parallel programs for a key asset with major FDA submissions/applications in 2023 and beyond. Will work closely with the Global Regulatory Lead and other regional leads to ensure strategic alignment.
You will contribute by:
Developing and implementing the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the GRL. Serving as the primary regional point of contact for the GRL, affiliates, and other Practices/Functions. Facilitating and coordinating the regulatory regional product team in collaboration with GRL to ensure that objective priorities are met. Being the primary contact point with the health authorities (FDA, EMA) building strong relationships. Ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated. Ensuring that the regional regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the GRL, GRA TA Head, GRA LT, and other functions and affiliates as needed. Coordinating the regional submission team. Delivering regulatory submissions in line with the applicable regulations, directives, and guidelines, and in line with agreed strategies and timelines. Ensuring all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc). Preparing and communicating regulatory strategic and operational plans for assigned projects. Assist in development of regulatory standards, efficient processes, and SOPs. Maintaining awareness of UCB and competitors’ activities in the region and share potential impact these activities may have on the product development program. Maintaining awareness of external regulatory environment, new guidelines, and legislation.
Interested? For this position, you'll need the following education, experience, and skills:
Bachelor’s Degree 8+ years 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.
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. Demonstrated experience facilitating and coordinating teams and processes with appropriate use of interpersonal skills. Experience building effective partnerships - identifies opportunities and takes actions to build effective relationships within 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 - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate. Sensitivity to the diverse cultures comprising- the international and global environment.
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
Regulatory Science Lead Anderlecht jobs
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