Healthcare & Pharma Careers

We are seeking a Regulatory Affairs Specialist in pharmaceutical Licensing for our client in Northeast Atlanta.. The role includes managing state pharmaceutical licenses for wholesale drug distribution, verifying client licenses, and supporting regulatory and Quality Assurance initiatives.. Experience with electronic Quality Management Systems (QMS) (preferred).. Regulatory Affairs certification (e.g., RAPS Medical Devices/Pharmaceuticals) (preferred).. Occupational Category: 13-1041.07 - Regulatory Affairs Specialists

Collaborate closely with cross-functional teams, including clinical operations, clinical development, biostatistics, pharmacovigilance, and regulatory affairs, to ensure alignment between medical writing activities and program goals.. Support medical affairs to ensure alignment between publications and congress presentations and clinical documents.. Qualifications and Skills Required: 10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development.. PhD or PharmD in Scientific Area preferred.. Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies.

Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.. Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA.. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives.. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants. 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products)

Director of Regulatory Affairs and Quality Assurance will oversee the activities of both Regulatory and Quality Assurance functions.. Review laboratory testing of raw materials, bulk product, and finished product in accordance with internal procedures and all applicable governmental regulations.. Maintain programs for documentation and technical assurance of raw material, packaging, bulk product, and finished product release specifications in addition to master batch instructions.. Develop staffing plan to manage resources needed to support any clinical trials, claim/label reviews, and regulatory reporting obligations.. Ensure supplier's chemical and microbiological testing programs (methods and sampling plans) for raw materials, packaging materials, In-process checks and finished products are adhered to, in order to guarantee product and process safety and conformance.

Through questioning the status quo and collaborating cross-functionally, the Senior Quality Assurance Auditor is responsible for leading, planning, scheduling, performing, and reporting a range of GxP audits across all phases of Clinical Research.. Title: Senior Quality Assurance Auditor (GCP Auditor)Who we’re looking for: Minimum of 2 years’ experience in quality assurance, auditing, including sound experience of applicable GxP auditing.. At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management.. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research.. Act as QA Lead on audits program(s).

Senior Manager, Medical WritingWho we are: is a biopharmaceutical company that is fueled by connections.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 5+ years as a medical or scientific writer, or equivalent professional or educational experience (eg, graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

Regulatory Affairs, Project Manager - Contract - Remote, Indianapolis Proclinical is looking for a detail-oriented and strategic Regulatory Project Manager to support a project with one of our clients in their Clinical Trial Patient Engagement Team. Primary Responsibilities:This role is critical in monitoring the evolving clinical trial regulatory landscape and ensuring compliance with current regulations.. The ideal candidate will conduct impact analyses, develop proactive response strategies, and stay updated on the latest drug development trends, policies, and regulatory changes to guide project decision-making.. Skills & Requirements:Minimum of 3+ years of experience in regulatory project management, clinical trials, or drug development.. In-depth knowledge of regulatory environments related to clinical trials and drug development.. The Regulatory Affairs, Project Manager's responsibilities will be:Regulatory Landscape Monitoring: Continuously track and analyse changes in the clinical trial regulatory environment and evaluate their potential impact on ongoing and future projects.

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.. The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice.. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

The Senior Director, Clinical Pharmacology at Kailera Therapeutics will report to the VP of Translational Medicine and will be responsible for the strategic design, execution, and interpretation of clinical pharmacology studies to support the development of novel therapies for diabetes and obesity-related diseases.. This role requires a deep understanding of clinical pharmacology principles, pharmacokinetics (PK), pharmacodynamics (PD), and model-informed drug development to advance Kailera's pipeline from early research through Phase 3 clinical trials.. Collaborate with Clinical Development, Biostatistics, Translational Medicine, CMC, Toxicology, Clinical Operations, and Regulatory Affairs to align clinical pharmacology strategies with overall program objectives.. Strong expertise in pharmacokinetics, pharmacodynamics, and model-informed drug development strategies.. Education: PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, or a related scientific discipline.

The Executive Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer.. Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets.. Develop and implement regulatory strategies for drug development that align with business objectives and timelines.. Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance.. Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development.

Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.. Responsible for providing Regulatory Affairs support to International RA Teams for product registrations, renewals to global markets for all US approved/cleared products including pharmaceuticals, medical devices, nutritional's and skin care products.. On Site administrative support with, approvals, dispatch and coordinating hardcopy file movement from international requestors to approval bodies and returns. Requirements: BSC in Biological Sciences or Regulatory Affairs, MSC Preferred.. Minimum 4 years work experience in Global/ International Regulatory affairs.

Attend scientific meetings and review literature to stay current with new developments in infectious diseases and therapeutic clinical research.. Experience in regulatory affairs, clinical research, and preparing regulatory documents.. Knowledge of regulatory documents, GCP, clinical trials, vaccine development, infectious diseases, drug development, IRB, IND, and BLA.. Professional or educational background in a scientific field, clinical trials, regulatory affairs, or healthcare.. General knowledge of the drug/vaccine development process or clinical trials is a plus.

In this role, the VP of Regulatory Affairs will draw on extensive experience and strong leadership and organizational skills to develop and implement the global regulatory strategy for all company assets.. Lead the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions.. Lead all interactions with regulatory agencies including coordination of Pharmacovigilance/Drug Safety reports.. Minimum of ten years of experience in regulatory affairs within the biopharmaceutical industry.. Knowledge of FDA regulations and EU CTA requirements required.

The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County.. The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.. Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities.. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.

This Senior Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division.. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed.. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.

This Senior Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division.. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed.. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.

Overview:We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join DermBiont.. Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.. Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP and to identify areas of non-compliance.. Provide knowledge of GLP and GCP, US Food and Drug Administration (FDA), International Council for Harmonization (ICH), Global Pharmacovigilance (GPV), regulations, guidelines, and industry standards.. Define and manage phase appropriate QA activities in support of preclinical studies and clinical trials.

Associate Director, Medical Writing, CTTD Who we are: Agios is a biopharmaceutical company that is fueled by connections.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 7+ years as a medical or scientific writer, or equivalent professional or educational experience (e.g., graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals.. The Director of Clinical Pharmacology will provide expertise and support to internal and external stakeholders in areas including, but not limited to, pharmacokinetics, pharmacometrics, drug metabolism, bioanalysis, and nonclinical pharmacology.. The incumbent will serve as the clinical pharmacology subject matter expert in cross-functional project teams and sub-teams, and lead the strategy, design, interpretation and reporting of clinical pharmacokinetics, pharmacodynamics, and drug-drug interaction studies.. Represent the clinical pharmacology function in cross-functional project teams including Project Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical/Medical Affairs, Biostatistics, and Regulatory Affairs.. Minimum of 10 years of experience in clinical pharmacology, pharmacokinetics and/or drug development in the pharmaceutical industry.

Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams across development (e.g., Global Development Team, Study Management, etc.). U.S. Education & Experience PharmD/PhD with 8+ years’ relevant experience.. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.. Experience leading global MAA filings for one or more regions and/or working extensively with global affiliates strongly preferred.. Knowledge & Other Requirements Demonstrated advanced knowledge of the drug development process, global and regional regulatory requirements for medicinal products.