Make your mark for patients
UCB 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 Atlanta, GA. It could also be based out of either our Raleigh, NC or Cambridge, MA locations. This will not be a remote position.
Please note: We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas at any point for this role. This includes taking over sponsorship for an existing Visa.
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): $137,160 to $160,020.
- (Cambridge, MA): $152,370 to $177,765.
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
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.
Requisition ID: 88228
Recruiter: John Gasbarre
Hiring Manager: Chris A. Graham
Talent Partner: Bianca Hinshaw
Job Level: SA II - SA I
Please consult HRAnswers for more information on job levels.
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