[Hiring] Global Labeling Lead @Sobi
Mar 18, 2025 - Sobi is hiring a remote Global Labeling Lead. đź’¸ Salary: $155,000-$190,000 annually. đź“ŤLocation: USA.
Role Description
The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
- Provides strategic and operational leadership on product labeling in collaboration with the Global Regulatory Leads (GRLs) and other stakeholders.
- Serves as a core member of the Global Regulatory Teams (GRT) for assigned products.
- Leads the coordination of content development and maintenance of the company Core Data Sheet (CDS), US PI, and EU SmPC.
- Ensures compliance with applicable Health Authority (HA) regulations and guidelines, internal company procedures, company core position, and business objectives.
- Manages the review and documentation of country labeling deviations for assigned products.
Key Responsibilities/Scope of the Job
- Lead the development, implementation, and maintenance of the CDS, US PI, and EU SmPC for Sobi products throughout their lifecycle via the Labeling Working Groups (LWG).
- Collaborate with internal stakeholders and with partner companies (where applicable).
- Lead cross-functional LWGs through all labeling discussions with the FDA/CHMP, ensuring management alignment and appropriate labeling governance.
- Document and archive the outcome of LWG meetings.
- Present outcomes to the Executive Labeling Committee for approval, where required.
- Act as point of contact for cross-functional teams on GRA labeling matters.
- Collaborate with Regulatory Leads for the development of the CDS, EU SmPC, and US PI.
- Collaborate with local/regional RA in their development of labels for first submission outside of EU and the US, ensuring alignment to the CDS.
- Ensure LWG review of deviations as assessed by local/regional RA and document outcome.
- Have oversight on the compliance status for the end-to-end tracking of safety variations for the assigned products.
- Ensure tracking of labeling projects via defined procedures and systems.
- Collaborate with Labeling Operations Coordinators (LOCs) as applicable.
- Support the development of Standard Operating Procedures (SOPs) and process improvements.
- Build cross-functional and cross-regional relationships.
- Provide support during inspections and audits.
Qualifications
- Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific field, e.g. in Pharmacy, Medicine, or Life or Natural Sciences.
- At least 8 years of working experience in the pharmaceutical industry or at a regulatory authority, with at least 5 years of experience in Regulatory Affairs, including CDS and EU/US Labeling experience.
- Experience of working in a global cross-functional environment.
Desired Qualifications
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
- Excellent personal and intercultural skills.
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner.
- Solution and detail-oriented; well-organized and self-motivated.
Skills/Knowledge/Languages
- Above-average proficiency with basic technology tools (e.g. MS-Office, etc.).
- Experience in Regulatory Information Management systems.
- Demonstrate excellent communication skills (oral/written/listening) in English. Knowledge of any other languages would be an asset.
Personal Attributes
- Results driven and team-oriented attitude with the ability to influence outcomes.
- Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously.
- Proven ability to innovate, especially with analyzing & solving problems, with minimal supervision and exceptionally keen skills for attention to detail.
- Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
Benefits
- Competitive compensation for your work
- Generous time off policy
- Summer Fridays
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments
Additional Information
The base salary pay range for this role is $155,000-$190,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.
COVID-19 Policy
For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.
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| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
đź’¸
$155,000-$190,000 annually
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 18, 2025
|
| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
