Make your mark for patientsUCB is looking for an exceptional
US Labeling Scientist who will lead development of new labeling content in collaboration with a cross functional project team. They will manage the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the assigned product Regulatory Leads, Regulatory Labeling as well as Advertising and Promotion Scientist Leads. They will also manage the compilation of labeling documents for all submissions which include labeling information as well as be responsible for drug listing for product manufactured by UCB for distribution within the US as well as establishment registration. This is a Hybrid role, ideally based out of our US Headquarters in Smyrna, GA. It could also be based out of our locations in Raleigh, NC or Cambridge, MA. This will not be a remote position.
Labeling Responsibilities:- Develop and maintain knowledge of US labeling regulations and industry standards
- Direct the labeling control process for changes to existing labeling
- Ensure consistency with the Global Labeling Function (GLF) and CCDS
- Manage Labeling Review Committee (LRC) packages and approvals
- Compilation of required labeling documents for all FDA submissions, including managing any artwork revisions
- Coordinate artwork revisions and FDA submissions
- Maintain drug product listings and establishment registrations; manage generation of and generate SPL for labeling submissions
Required Experience:- Bachelor's degree
- At least 2 years of relevant experience in the pharmaceutical industry with preferably one year in Regulatory Affairs and specific experience in US Labeling
- Basic knowledge of US labeling regulations and guidance
- Knowledge of science and data of assigned products and how that translates into labeling language
- Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling
- Product launch experience preferred
Required Competencies:- Integrity: overriding commitment to integrity and high standards in self and others
- Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence
- Strategic orientation: ability to link visions and daily work
- Communication: ability and intention to effectively explain, describe or convey information to a variety of audiences. Specifically, effectively communicate strategies to Supply Chain regarding implementation of new labeling revisions into product packaging. Also effectively communicates with Review Services in coordinating OPDP submissions
- Flexibility/adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups
- Relationship building, teamwork and cooperation. Builds or maintains friendly relationship with people and demonstrates desire to work
Compensation Range (Atlanta, GA or Raleigh, NC): $87.300 to $127,050
(Cambridge, MA): $105,390 to $147,630
If you are interested to learn more about R&D within UCB, please find more information hereR&D at UCB.
RANDATUCB
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 usUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 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 equitable 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.
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 US-Reasonable_Accommodation@ucb.com 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.
Job Req: 87797 
