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.
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.
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.
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”.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
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.
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.
Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
Perform review of executed batch records and test data and perform product disposition
Lead and support quality audits of contract service providers
Jobgether is a company that connects job seekers with employers through an AI-powered matching process. They focus on ensuring applications are reviewed quickly and fairly, and they value talent development.
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.
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.
Sobi is dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
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.
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.
Acting as first point of contact for all inbound compliance queries, routing matters as necessary to appropriate team members and tracking completion
Supporting and coordinating recurring compliance tasks that help mitigate regulatory risk to the company
Assisting with preparation and submission of routing regulatory filings such as state registrations and annual reports
Virta Health is dedicated to reversing metabolic disease in one billion people through personalized nutrition and virtual care. They have raised over $350 million and partner with health plans, employers, and government organizations.