Regulatory Affairs Specialist

What You Need to Know About Regulatory Affairs SpecialistExample of Regulatory Affairs Specialist Job: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.Regulatory Affairs Specialist Responsibilities ...

About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.Our 114,000 colleagues serve people in more than 160...

Job Title: Regulatory Affairs AssociateAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.We are seeking a highly motivated individual to provide support to global regulatory activities in obtaining worldwide approvals to...

Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a seasoned professional to fill the role of Director, Global Regulatory Affairs, Development Strategy for a leading global biotechnology company.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful...

A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. Key Responsibilities Develop and execute U.S. regulatory advocacy strategies and action plans Monitor and analyze U.S. regulatory guidelines, regulations, and policies related to medical devices Lead the preparation of document packages for regulatory...

EMPLOYER: AstraZeneca Pharmaceuticals LPTITLE: Associate Regulatory Affairs DirectorLOCATION: Gaithersburg, MDHOURS: Full-Time; Mon-Fri (40 hours/week)DUTIES: Lead the end-to-end planning, coordination, and execution of assigned deliverables. Contribute to regulatory submission strategy, identifying submission risks and opportunities. Lead regulatory...

Job Title: Regulatory Affairs AnalystAt Air Movement and Control Association International, we are seeking a highly skilled Regulatory Affairs Analyst to join our team. As a key member of our advocacy services, you will play a critical role in analyzing proposed and final regulations, bills, and codes/standards changes.Responsibilities:Prepare advocacy...

Job Title: VP, Quality & Regulatory AffairsStratasys is seeking a highly experienced and skilled VP, Quality & Regulatory Affairs to lead all aspects of quality assurance and regulatory compliance across the Global Enterprise.Key Responsibilities:Develop and implement a comprehensive quality strategy that aligns with the company's goals and...

Job Title: Sr. Manager, Regulatory AffairsThermo Fisher Scientific is seeking a highly experienced Sr. Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies for product approvals and compliance in the US and Canada.Key...

A company is looking for a Director of Regulatory Affairs, Lifecycle. Key Responsibilities Oversee the Lifecycle Regulatory team and manage personnel activities Develop and execute global regulatory strategies for commercialized products Ensure compliance with regulatory Conditions of Approval and oversee advertising and promotion reviews Required...

Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...

Job Title: Director of Regulatory Affairs CMCWe are seeking a highly skilled and experienced Director of Regulatory Affairs CMC to join our team at GSK. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the timely and successful submission of CMC regulatory documents to support the development,...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway,...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Job Title: Head of Global Labelling - Regulatory Affairs Job Type: Full time permanent position Locations: UK, France, Germany, Ireland, Netherlands, Norway, and the United States of America (Remote) Remuneration: Competitive salary and benefits packageWorking for one of the industry's leading pharmaceutical companies, this is a fantastic opportunity to...

Vice President, Regulatory Affairs & Quality AssuranceThe Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that regulatory requirements are met, and 2) obtain regulatory approval for Pulmonx products. The VP oversees compliance to quality regulations and standards. The VP oversees the...

The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable. The...

Duration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.