Biotech Regulatory Affairs Director

At BioSpace, we are seeking a highly skilled Biostatistician Leader to join our team in Clinical and Statistical Sciences. This is an exciting opportunity to lead statistical support across various non-clinical areas, focusing on Chemistry, Manufacture and Control (CMC) and expanding the application of biostatistics.About the RoleThe Associate Director in...

The Chief Manufacturing Operations Director at Grassi will play a pivotal role in driving the company's manufacturing operations to new heights of efficiency and productivity.About the RoleWe are seeking an experienced leader to oversee all aspects of our manufacturing operations, including pharmacy, blending, compression, packaging, and warehousing...

About the OpportunityWe are seeking a highly skilled Senior Utilities Infrastructure Project Director to lead our utilities engineering projects. As a key member of our team, you will be responsible for overseeing projects related to utility design, coordination, and construction.Key ResponsibilitiesManage and supervise utilities engineering projects,...

Lead a Groundbreaking Crisis ProgramAs the Senior Mental Health Services Director for our new Crisis Receiving and Stabilization Center in Morris County, NJ, you will have the opportunity to shape the future of mental health services in this community.About the RoleThis is a full-time position responsible for overseeing all aspects of our crisis program,...

About the RoleThe Care Coordination Director will lead a dedicated team to guarantee that each client's home care plan meets their needs, family expectations, and regulatory requirements.This includes maintaining continuous communication and coordination with referral sources, family members, clients, healthcare providers, and intake teams.You'll oversee...

We are seeking a seasoned Senior Quality Assurance Director to oversee the quality of our products and processes. As a key member of our team, you will ensure that our products meet the highest standards of quality, safety, and reliability.About the RoleThis is a senior leadership position responsible for leading the quality assurance function across our...

We are seeking an experienced IT Project Director to join our team at Onco360 Pharmacy. This unique oncology pharmacy model serves the needs of community, oncology and hematology physicians, patients, payers, and manufacturers.As a Transformational IT Leader, you will be responsible for planning, executing, and finalizing technology projects within scope, on...

We are seeking an experienced and progressive Clinical Supervisor to oversee the clinical and social services functions at our men's mental health shelter in Ozone Park, Queens. This role is responsible for optimizing the quality of care to residents in accordance with DHS regulatory and accreditation requirements.Key Responsibilities:Develop and supervise...

Role OverviewAction Behavior Centers is a leading provider of Autism Spectrum Disorder (ASD) treatment services. We are seeking an experienced BCBA Clinical Director to lead our clinical operations and team in Apex, NC.The ideal candidate will possess strong leadership skills, experience working with ASD clients, and a passion for delivering high-quality...

World Courier Inc is a leading provider of specialized transportation and logistics solutions. We are committed to delivering high-quality services to our clients, and we are seeking a highly skilled Regional Quality Operations Lead to join our team.The estimated salary for this role is $120,000 - $180,000 per year, depending on experience and...

At the Culinary Institute of America, we are committed to delivering exceptional patient care and service. We offer a competitive salary range for this position, estimated to be between $95,000 and $115,000 per annum, depending on experience.Job DescriptionThe Charge Nurse is responsible for overseeing the smooth and efficient operation of our Health...

Job OverviewOnet-Systems is a leading provider of out-of-network medical revenue cycle management solutions. Our company specializes in supporting healthcare providers through claims processing, arbitration support, and regulatory compliance.Salary Estimate: $120,000 - $150,000 per year.Key Responsibilities:Lead the arbitration process under the No Surprises...

At FlexStaff, we are seeking a highly skilled Psychiatric Nurse Practitioner to join our team of healthcare professionals.About the Role:We are looking for a dedicated and compassionate individual to provide psychiatric services in an outpatient setting. The successful candidate will be responsible for promoting and maintaining health and wellness by...

About Us">Lantern Community Services Inc is a leading provider of mental health services, dedicated to creating vibrant, healthy, and just communities.">Job Overview">We are seeking an experienced and progressive Director of Social Services to oversee our men's mental health shelter. This role will lead the Clinical and Social Services functions to optimize...

Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...

Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...

Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...

Lead Regulatory Affairs efforts for Orca Bio, a late-stage biotechnology company developing cell therapies.The ideal candidate will have 12+ years of regulatory experience, including 8+ years in leadership within the biotech/pharmaceutical industry or as a seasoned regulator.We offer a competitive salary range of $180,000 - $250,000 based on prior...

Unlock Career Opportunities at Orca BioWe are driven by a passion for science and compassion for patients. Our goal is to ensure that our treatments are accessible to all who need them.As a leading biotech company, we value excellence in our work and the chance to unlock a better quality of life for our patients. We take tremendous responsibility for...

Location: Florham Park, NJ - Onsite 50% (2-3 days per week)Duration: 1 YearOverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of...

Overview The Senior Manager, Regulatory Affairs-GDP - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional...

Overview The Senior Manager, Regulatory Affairs-GDP - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional...

Join Orca Bio, a late-stage biotechnology company redefining the transplant process with next-generation cell therapies. As our Head of Regulatory Affairs, you will lead our regulatory strategy and operations.Role OverviewThis role is ideal for a seasoned regulator or leader with 12+ years of experience in regulatory affairs within the biotech/pharmaceutical...

Insight Global is seeking a Sr. Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for assisting with the development and execution of regional regulatory strategies for its therapeutics division. It is essential that this person has experience working with therapeutics and possesses a...

Insight Global is seeking a Sr. Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for assisting with the development and execution of regional regulatory strategies for its therapeutics division. It is essential that this person has experience working with therapeutics and possesses a...

Insight Global is seeking a Sr. Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for assisting with the development and execution of regional regulatory strategies for its therapeutics division. It is essential that this person has experience working with therapeutics and possesses a...

Insight Global is seeking a Sr. Manager of Regulatory Affairs to join one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for assisting with the development and execution of regional regulatory strategies for its therapeutics division. It is essential that this person has experience working with therapeutics and possesses a...

Responsibilities: Manages most aspects of company regulatory interface with domestic and international health authorities. Manages the development and deployment of the regulatory program that ensures aggressive product approval. Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings,...

JOB DESCRIPTIONInsight Global is seeking an Associate Director of Regulatory Affairs to join the one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for developing and executing regional regulatory strategies for antiviral products. It is essential that this person has experience working with therapeutics and possesses a...

JOB DESCRIPTIONInsight Global is seeking an Associate Director of Regulatory Affairs to join the one of our pharmaceutical clients in Florham Park, NJ. This position is responsible for developing and executing regional regulatory strategies for antiviral products. It is essential that this person has experience working with therapeutics and possesses a...

Purpose As our Senior Manager of Rates and Regulatory Affairs you will collaborate with the Transformation and Regulatory Teams, contributing to the success of rate case filings across multiple states and commodities. Reporting to the Senior Director, Rates & Regulatory Affairs, you will be instrumental in preparing regulatory materials and supporting...

Overview The Senior Regulatory Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and HealthCanada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions, to ensure compliance with applicable laws and regulations. The scope of this role...

Job DescriptionJob DescriptionWork Location: Irwindale, CaliforniaSalary Range: $80,000 - $140,000 depending on related working experienceJob Type: Full-Time OnsiteOur Company:Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care...

Managing Director of Development and External Affairs Location: Chicago, IL Impact for Equity, a highly regarded and impactful public interest law and policy center, seeks a mission-driven Managing Director of Development and External Affairs. The Managing Director provides overall leadership and strategic oversight for all aspects of Impact for Equitys...