Source Job

• 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.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

• 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.

• Coordinate and compile regulatory submissions.
• 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.

• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
• Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.

Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.

• 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.

• 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”.

• Maintain current knowledge of applicable laws and regulations.
• Interpret regulatory requirements for products and ensure compliance.
• Participate as a regulatory representative on project teams.

Kansas General focuses on developing and implementing long-range regulatory strategies. The job posting does not mention the company size or culture.

• 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.