Sr Labeling Scientist Senior Manager US 89251
Sr Labeling Scientist Senior Manager US 89251
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$ 121900 - 160000
1 Vacancy
Job Description
Make your mark for patients
We are seeking an experienced US Senior Labeling Scientist (Senior Manager) to play a pivotal role in shaping the strategic direction of product labeling working closely with crossfunctional teams to ensure that labeling aligns with both regulatory requirements and business goals.
In collaboration with the Regulatory Advertising and Promotion (A&P) representative this role is instrumental in the development and optimization of key regulatory documents such as the TPVP TCLP and CCDS. By providing strategic input the Senior Labeling Scientist (Senior Manager) ensures that local labeling not only meets FDA guidelines but also supports competitive positioning market access and effective product promotion in the US market.
About the role:
Strategic Labeling Development:
- Lead the development and maintenance of US product labeling ensuring it aligns with the CCDS and adheres to FDA regulations and guidelines.
CrossFunctional Collaboration:
- Serve as a strategic leader in the US Labeling Review Committee (LRC) facilitating productive discussions to gain alignment across functions and ensure that all stakeholders are informed and engaged in the labeling process.
Labeling Artwork Strategy:
- Lead the development of product labeling artwork by providing clear strategic regulatory input on content layout and visual elements. Ensure that the artwork complies with FDA regulations and enhances the marketability of the product while maintaining regulatory integrity.
Regulatory Leadership and Guidance:
- Act as the goto expert for regulatory labeling matters providing guidance and oversight to the US Labeling Scientist and other teams as needed.
Who youll work with:
The Senior Labeling Scientist (Senior Manager) will partner with the US Regulatory Science Lead and crossfunctional subject matter experts to drive consistency and regulatory compliance across product labeling. Collaborate closely with the Regulatory A&P representative to ensure that labeling is optimized to support both regulatory compliance and marketing objectives.
Additionally the Senior Labeling Scientist (Senior Manager) ensures that the US Advertising and Promotion representative is actively involved in labeling development discussions providing key insights into how the labeling may impact promotional strategies and ensuring alignment with product messaging.
What youll do:
- US Regulatory expert regarding requirements for US regulation of drug labeling.
- Engage in TPVP TCLP and CCDS discussions to support development of competitive US labeling.
- Lead development and maintenance of US product labeling consistent with the CCDS and FDA regulations/guidelines
- Lead Labeling Review Committee meetings to gain labeling alignment among crossfunctional subject matter experts.
- Provide competitive labeling landscape for reference in labeling development.
- Participate in process improvements to enhance efficiency of labeling development and maintenance.
Interested For this position youll need the following education experience and skills:
- Bachelors degree in health sciences business or related field is required.
- Minimum of 7 years experience in Regulatory Affairs and 5 years experience in Regulatory labeling strategy.
- In addition a minimum of 2 years of Regulatory advertising and promotion review experience.
- Expert knowledge of US laws regulations and guidances related to pharmaceutical product labeling development.
- Demonstrated examples of strong leadership communication interpersonal skills and an ability to strategically both assess and navigate risk.
- Well established ability to work collaboratively and influence crossfunctional teams manage multiple projects and prioritize competing deadlines.
- Proven track record of thinking strategically and creatively to regulatory challenges.
This positions reasonably anticipated base salary range is $121900 $160000 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 colour 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:
Senior Manager
Employment Type
Full-Time
