Regulatory Affairs Senior Manager

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...

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...

About the RoleGilead Sciences, Inc. is a biopharmaceutical company dedicated to creating a healthier world for all people. As a Senior Manager, Regulatory Affairs CMC, you will play a critical role in providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.Key...

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

Job Title: Sr. Regulatory Affairs SpecialistTeleflex is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our Global Operations organization, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...

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...

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 ...

A company is looking for a Senior Counsel, Product and Regulatory Affairs (Liquidity). Key Responsibilities Provide regulatory advice on U.S. and international digital asset laws Support the product team in developing digital asset products and services Stay updated on securities law and crypto developments to support commercial initiatives ...

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...

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...

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,...

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...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

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...

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...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D requests,...