The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders.
As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
Implement action plans to achieve timely approval of submissions ensuring compliance
Participate in and support project teams to achieve regulatory goals
Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.
Implement action plans for approval of submissions.
Improve internal processes and foster relationships.
They are a company using AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Provide technical leadership for regulatory submissions.
Manage vendor relationships and internal SOPs.
Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They embrace innovation and achieve results through cooperation and the integration of multiple viewpoints, with a focus on radical care.
Lead the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights for internal teams.
Hims & Hers is a health and wellness platform with a mission to improve health around the world. They are customer-centric, and focused on affordability, access, and personalized care. Hims & Hers is a public company traded on the NYSE under the ticker symbol “HIMS”.
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
Remain current on regulations and best practices within the industry
Nuvalent is dedicated to creating selective medicines to address the unmet needs of patients with cancer, leveraging their expertise in chemistry. As an early-stage entity, Nuvalent brings together seasoned scientists and industry experts with a strong history in oncology drug development, drug discovery, and company building.
Drive global regulatory strategy for peptide and nucleic acid-based products.
Collaborate with teams to ensure compliance with international standards.
Prepare CMC documents and regulatory submissions for complex products.
Jobgether is dedicated to connecting talent with opportunities. They leverage AI-powered matching to ensure applications are reviewed quickly and fairly, identifying top candidates for hiring companies.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
Establish and lead the clinical operations strategy, setting departmental goals.
Promote strong cross‑functional collaboration with internal stakeholders.
McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.
Build and mature core elements of Rula’s enterprise Compliance Program.
Ensure adherence to federal and state healthcare regulatory requirements across Rula’s clinical operations.
Lead compliance risk assessments and internal controls; oversee investigations and corrective action processes.
Rula is dedicated to treating the whole person and aims to create a world where mental health is no longer stigmatized. Rula is a remote-first company that is passionate about making a positive impact on the lives of those struggling with mental health issues.
Contribute to strategic development and growth planning.
Mentor and develop a high-performing team.
Jobgether is a platform that uses AI to match candidates with jobs. The company values opportunities for professional development, flexible work arrangements, and an inclusive company culture.
Oversee the Enterprise Export Control Compliance Program and ensure adherence to applicable Export Control and Research Security regulations.
Collaborate with various departments to provide expert guidance and support for compliance initiatives.
Contribute to the organization's mission to provide patient-first care while managing risks related to export regulations.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They use AI tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses.
Define and execute compliance program strategy across various domains.
Lead enterprise-wide compliance programs with multi-year timelines.
Create scalable compliance frameworks and integrate processes across products.
Jobgether connects job seekers with opportunities at partner companies. They use an AI-powered matching process to ensure applications are reviewed quickly and fairly.
Achieve mandatory Medical Device Regulation certification to maintain European market access.
Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.
Docplanner Group aims to help people live longer, healthier lives by connecting patients with doctors across 13 countries. With 3,000+ employees, they provide marketplaces, SaaS, and AI tools to simplify daily tasks for healthcare professionals.
Manage a portfolio of sponsor and client accounts, leading recurring calls, business reviews, and ad-hoc engagements.
Drive responsiveness and service levels for sponsor requests, communicating with accuracy and awareness of business risks.
Translate sponsor goals into cross-functional delivery plans.
Jobgether is a company that uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Partner with product managers, designers, engineers, marketers, and researchers in understanding key user needs.
Build user flows, wireframes, prototypes, and high-fidelity designs to communicate solutions to cross-functional partners.
Translate business goals and regulatory constraints into clear, intuitive, and compliant user experiences.
Achieve is a digital personal finance company that helps people move from struggling to thriving by providing innovative and personalized financial solutions. They have over 3,000 employees in mostly hybrid and 100% remote roles across the United States with hubs in Arizona, California, and Texas.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.