Clinical Regulatory Strategist – Fractional IND/CTA Specialist

The Project Associate will drive and support overall project management activities to ensure successful execution of clinical trials. · ...

The Regulatory Submissions Specialist is responsible for preparing, assembling, processing, formatting, quality controlling publishing submitting archiving submissions (e.g., IND CTA BLA Amendments Supplements Annual Reports IMPD Briefing Documents) to US CA other international h ...

Proclinical is seeking a Senior Director Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the San Francisco Bay Area California. · In this role you will lead global regulatory strategy and operations across the companys development pipel ...

We're partnering with a leading Boston-based oncology biotech to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline. · ...

We are looking for an experienced Regulatory Affairs Associate who has worked on clinical trial applications (CTAs) for small drug molecules. · ...

Position: AD, Regulatory Affairs · Location: San Francisco (Hybrid) · Reports To: Senior Director, Regulatory Affairs · Compensation: $180-220k base salary + annual bonus + stock options · About the company: With nearly half a billion in total funding, this Rare disease biotech b ...

Regulatory Affairs Specialist · Remote · W2 Only · We are seeking an experienced Senior Manager, Regulatory Affairs to support global regulatory activities and key submission deliverables for our growing biotech organization. This role is well-suited for someone who is hands-on ...

The Global Regulatory Head directs the regulatory strategy and submissions for the company's RLT portfolio. · ...

Skills Alliance has been retained by a Seattle-based startup focused on developing dual-payload Antibody Drug Conjugate (ADC) treatments in the oncology space. This company is backed by the industry's top investors, and raised nearly $200 Million last year. · Right now, they are ...

Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in West Point, PA to work for an innovative and growing pharmaceutical manufacturer. · ...

Onsite 5 days a week - Candidates must be located in San Diego, CA · The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. This role serves as the regulatory lead on cross-functional CMC teams and ...

The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs.This role serves as the regulatory lead on cross-functional CMC teams and is responsible for authoring, managing, and overseeing high-quality gl ...

A Clinical Pharmacology leader will support the development of dual-payload Antibody Drug Conjugate (ADC) treatments in the oncology space. · Lead Clinical Pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, · Clinical Sample Analysis, D ...

· Full-time · DescriptionLead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs, · Query responses, audit support, and lifecycle management. · Regulatory support for the filing of IND/CTA to various regulatory agencies.  · Maintenance of IND/C ...

Partnering with a high-growth clinical-stage biotech using human genetics to develop precision small-molecule medicines. · This is a hands-on Associate Director role supporting global regulatory strategy across multiple clinical programs. · ...

Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in Lansdale, PA to work for an innovative and growing pharmaceutical manufacturer. · Responsibilities for the QA Clinical Supplies Specialist: · Electronic batch record review of finished clin ...

The AD, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. · Serve as CMC regulatory lead, providing strategic guidance and regulatory oversight. · ...

Piper Companies is looking for an experienced QA Clinical Supplies Specialist in West Point, PA to work for an innovative and growing pharmaceutical manufacturer. · Electronic batch record review of finished clinical goods to ensure clinical supplies are incompliance with cGMP an ...

Piper Companies is looking for an experienced QA Clinical Supplies Specialist in West Point, PA to work for an innovative and growing pharmaceutical manufacturer. · ...

We are looking for a skilled Regulatory CMC Director to lead our commercial and development projects. · Responsible for regulatory CMC leadership of one or more commercial and development projects. · ...