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.

Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.. Reviewing of PMs, Pest Control, Calibration records, etc.. Minimum Requirements: The QA Supervisor must have at least 5-7 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance or Quality Control.. Education and Experience: BS Degree or BA Degree with a Science major or concentration and continuing education credits in the pharmaceutical industry through a reputable professional society.. An Associate degree with 10 plus years in pharmaceutical manufacturing experience will be considered.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.. Requirements: Bachelor's Degree in Science (Biology; Chemistry; Microbiology; Immunology; Medical Technology; Pharmacy; Pharmacology); Math; Engineering; or Medical fields is preferred.. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.). Individuals with "hands-on”/authoring experience with US k submission or EU MDR/IVDR technical files.. Individuals with practical experience working with in vitro diagnostics medical devices.

Job Title: QA/RA Manager (Quality Assurance and Regulatory Affairs Manager) - IVD. Ensure that all in vitro diagnostic products meet applicable quality standards, including the management of product development, manufacturing processes, and validation activities.. Qualifications: Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master's or MBA preferred).. Strong understanding of the IVD product lifecycle, from development to post-market surveillance.. Certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., Six Sigma, ASQ Certified Quality Manager) is a plus.

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.

With a newly qualified manufacturing facility and plans to scale production, we are seeking a Head of Quality Assurance and Regulatory Affairs to ensure compliance and excellence in quality and regulatory practices.. Position Overview: The Director of Quality Assurance and Regulatory Affairs will oversee the quality management system (QMS), ensure compliance with global medical device regulations, and provide strategic leadership to the quality and regulatory teams.. Qualifications: Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.. Strong knowledge of global medical device regulations, including FDA and ISO/CE standards.. Experience managing QMS compliance, regulatory submissions, and product lifecycle management.

Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast.. Coordinates and/or completes applications for initial submission to the Institutional Review Board (IBC) for review including assisting with protocol development activities, completing required application forms, and creating consent forms to meet JMC and sponsor standards.. and respond to Institutional Review Board requests.. Analyze and submit unanticipated adverse events (AEs) and serious adverse events (SAEs) and deviation reports to the IRB as required by sponsors and, if appropriate, make changes to the consent form to reflect new information about adverse events; provides support to internal/external staff in completing AE or SAE reports for submission to study sponsors and IRB.. Serves as information specialist and resource for regulatory, ethical and methodological questions and issues from staff.

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.

Job Description Job Description · As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment.. · Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. Regulatory areas are preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Preferred Qualifications: · Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.. · Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents, Regulatory agency structure, processes and key personnel.

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.

About Madrigal: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).. Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts.

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.

They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space.. Contributes to the strategy for US FDA interactions with the cross-functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs∯*∯ Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams.. Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals.. Requirements/Key Attributes:Master's or above degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology, or comparable preferred; bachelor's degree in a scientific field required.. 8+ years' experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred.

A small but growing clinical stage company is seeking an Associate Director Regulatory Affairs to join the team in a remote capacity.. They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space.. Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams.. Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals.. 8+ years' experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred.

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems