Regulatory Science Lead Associate Director of Regulatory Affairs 88856
Regulatory Science Lead Associate Director of Regulatory Affairs 88856
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Job Description
Make your mark for patients
We are looking fora Regulatory Science Lead (Associate Director of Regulatory Affairs) who is a proactive collaborative and strategically minded individual to join us in our US Regulatory Affairs team based in our Smyrna (Atlanta GA) or RTP (Raleigh NC) offices. Our team operates in a hybrid work model.
About the role
The Regulatory Science Lead (Associate Director of Regulatory Affairs) will be responsible for all regulatory activities related to product development and marketing authorizations in the US and is the primary contact point within UCB for any regulatory issues with the product and with designated health authorities.
Who youll work with
The Regulatory Science Lead (Associate Director of Regulatory Affairs) will successfully collaborate & partner with members of the US Regulatory Affairs department within the Immunology therapeutic area. Additionally a qualified candidate will partner with crossfunctional and international teams to support UCBs Regulatory Affairs goals.
What youll do
- Develops and implements 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 Global Regulatory Lead.
- Responsible for 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.
- Deliver regulatory submissions in line with the applicable regulations directives and guidelines and in line with agreed strategies and timelines.
- Assist in development of regulatory standards efficient processes and SOPs.
- Maintain awareness of UCB and competitors activities in the region and share potential impact these activities may have on the product development program.
- Maintain awareness of external regulatory environment new guidelines and legislation.
Interested For this role were looking for the following education experienceand skills
- Minimum of a Bachelors degree: Masters degree preferred.
- A minimum of 5 years of progressive experience in the Pharmaceutical Biotechnology and/or CRO industry is required.
- 10 years pharmaceutical experience in Regulatory Affairs preferred.
- Demonstrated experience building effective partnerships:
- Identifies opportunities and takes actions to build effective relationships within and across teams with appropriate use of interpersonal skills and sensitivity to diverse cultures comprising the global work environment.
- Proven track record of Influencing skills:
- Thorough wellthought through rationale and effective communication skills able to influence key decisions.
- Well established communication skills:
- Knows when and how to communicate using strong interpersonal skills and written communications when appropriate.
- Strategic and results focused:
- Ability to overcome obstacles and achieve key outcomes
- Strong Project planning and management skills:
- Ability to perform risk assessments anticipating problems and providing creative solutions.
This positions reasonably anticipated base salary range is $141800 $186100 per year. The actual salary offered will take into account internal equity and may also vary depending on the candidates geographic region jobrelated 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 around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 equitable opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats 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.
As an Equal Opportunity Employer we are open to all talent and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity race/ethnicity color national origin religion gender pregnancy marital status sexual orientation gender identity/expression age disability genetic information military service covered/protected veteran status or any other federal state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on 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.
Required Experience:
Director
Employment Type
Full-Time
