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.
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.
Represent the Regulatory Affairs function within project teams.
Develop and implement regulatory strategies that support business goals.
Collaborate with international partners and internal teams.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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.
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.
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.