Healthcare & Pharma Careers

Enjoy problem-solving, need a venue to display your creativity, and emerging technologies pique your interest; if so, Barrow Wise Consulting, LLC is for you.. Barrow Wise is an equal-opportunity, drug-free employer committed to diversity in the workplace.. Minority/Female/Disabled/Protected Veteran/LBGT are welcome to apply.. Our employees stand behind Barrow Wise's core values of integrity, quality, innovation, and diversity.. We are confident that Barrow Wise's core values, business model, and team focus create positive career paths for our employees.

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.

Reporting to the Vice President of Regulatory Affairs, this position is specifically responsible for the oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives.. Acts as regulatory operations representative for drug development programs via the project team by identifying, driving, tracking and delivering key milestones/objectives. Acts as back up to Vice President, Regulatory Affairs on an as needed basis. Prepares needed regulatory operations Standard Operating Procedures (SOPs); provides regulatory review of SOPs from other departments as necessary. Direct experience in preparing registration (IND, NDA, BLA, and/or MAA) submissions required

Regulatory Affairs Specialist. The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup.. The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings.. This role will work independently on some submissions and partner with others in the Regulatory Team on other US FDA filings, including IDEs, 510(k)s and PMA. This position requires someone with both a strong execution mindset and ability to explain regulatory processes to the organization.. Experience with complex medical devices, incorporating electro mechanical and disposable components highly desired

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.

The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.. Provide innovative and proactive regulatory strategy for CMC development of gene therapy products for all project teams in early research and all stages of clinical development.. Minimum 10 years experience working in Regulatory Affairs; ideally 7 plus years in the biotech industry (gene therapy, monoclonal antibodies, vaccines, blood products, and/or cell products) including preferably experience in a small biotech company environment. Pharmaceutical industry experience in successfully transitioning from Phase 1 clinical trial material to Phase 3 and commercial GMP quality material with a record of successful product approval in the US, EU, Asia and pre-approval inspection success.. Demonstrated strategic thinking and problem-solving for CMC issues in the rapidly developing field of manufacturing gene therapy products.

Orbital Therapeutics is on a mission to enhance global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible.. We are building a portfolio of innovative RNA medicines across three areas – immunomodulation for autoimmune disease and oncology, next-generation vaccines, and protein therapeutics.. Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company’s quality strategy and operations.. Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.. Experience in RNbased or gene therapy products is highly desirable.

Job Title: Regulatory Affairs Specialist. Our client is seeking an experienced Regulatory Affairs Specialist to lead regulatory strategy and submissions for medical devices.. Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.. 3-5 years of regulatory affairs experience within the medical device industry.. Regulatory Affairs Certification (RAC) or equivalent credential (preferred).

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care.. In the role ofa Clinical Research Quality Assurance Specialist Iyou will beworking in our Cancer Center.. PurposeUnder close supervision the Clinical Research Quality Assurance Specialist I is responsible for the oversight of clinical research study protocols with an emphasis on quality, training, monitoring, and the development of tools for study team use.. The Clinical Research Quality Assurance Specialist I will coordinate the day-to-day administrative activities of the program and will provide support to teams to facilitate the achievement of the program’s goals.. Assist in resolving clinical research non-compliance through root cause analysis, corrective, and preventative action plansKnowledge – Skills – Abilities Basic knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures.

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.

MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs.. Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities. Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings. Bachelor's degree in a scientific discipline; Graduate degree (Ph. D. or PharmD) strongly preferred. Progressive related experience in regulatory affairs in the pharmaceutical/biotech industry

About you: BS Degree is required/preferred; an advanced degree (Masters, PharmD, PhD) is a valuable asset; an equivalent combination of education and experience. Extensive regulatory experience, including IND/CTA, BLA/MAA, life-cycle management, interactions with Health Authorities, and leading and managing teams.. Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases.. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein.. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

Pioneering innovation in the biologics space, we are developing a diverse platform for various therapeutics including proteins, antibodies, peptides, cytokines, and vaccine allergens, targeting disease indications ranging from infectious to metabolic diseases.. The novelty of our products and GMP biomanufacturing process create many opportunities to think creatively about improving conventional biopharmaceutical development, including the regulatory process.. ; familiarity with GMP, GCP, and GLP; and. Strong writing and editing skills; particularly helping others learn to write in “FDA regulatory style,” including some for whom English is not the first language.. Impatience for the slow pace and extreme cost of conventional biopharmaceutical development; a distaste for mindless proceduralism for its own sake.

Senior Representative, Regulatory Affairs Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.. The Regulatory Affairs department is accountable for the direct management and guidance regarding the organization’s cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, inhalation manufacturing and analytical services.. The main responsibility of a Senior Regulatory Affairs specialist is to serve as a regulatory liaison to clients and internal functional departments.. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.

Additionally, the company is developing Bicycle Radio Conjugates (BRC) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.. Job Description The Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.. Monitor the CMC regulatory landscape e.g., views of HAs, regulatory precedents, labeling differences and other CMC-specific issues, to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects. Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry; particularly relating to peptides, drug-conjugates and/or radiopharmaceuticals; any in-depth experience may be limited to one specific region (e.g. US or EU). Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations

Senior Director of Translational Medicine and Clinical Pharmacology Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products.. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than countries across the globe.. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.. Description: Sun is seeking a director/senior director within its Translational Medicine and Clinical Pharmacology group in Princeton, NJ. The director will report into Vice President of Translational Medicine and Clinical Pharmacology.. Leadership of the early clinical development strategy for novel therapy programs from preclinical candidates through initial clinical testing (Phase 1) and clinical Proof-of-Concept (Phase 2) Development and execution of clinical pharmacology strategies to support later stages of development from Proof-of-Concept (Phase 2) through worldwide marketing application Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group.

Job DescriptionDirectly reporting to the Lead Clinical Research Associate for a designated area(s) of the Clinical Trials Department, under limited supervision, coordinates and manages clinical trials in accordance with federal, and state regulations, Institutional Review Board approvals and Connecticut Children's policies and procedures.. Provides timely information regarding each clinical trial visit to all ancillary departments as required e.g., Office for Grants and Sponsored Programs, pharmacy, institutional review board, etc. STUDY START-UP/CLINICAL TRIAL INITIATION (performs responsibilities under limited supervision):•Participates in Connecticut Children's internal study start-up process and works collaboratively with the study team to prepare study for activation.. Preferred: N/AKnowledge, Skills and AbilitiesKnowledge of:Demonstrates a fundamental knowledge of research protocols including each element of the protocol, investigational product development, clinical research participant safety and related documentation and reporting practices, research regulations, human research protection principals and Good Clinical Practice (GCP) guidelines.. Our breakthrough research, superior education and training, innovative community partnerships, and commitment to diversity, equity and inclusion provide a welcoming and inspiring environment for our patients, families and team members.

Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.. Exciting Opportunity at MSK: For a Clinical Trials Nurse at Memorial Sloan Kettering Cancer Center's Westchester location.. Coordinate patient care activities and participate in the conduct of studies for patients enrolled in clinical trials for multiple services including The Early Drug Development (EDD) Service.. MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment.

As the Director of Clinical Research, you will take the helm of cutting-edge clinical studies that push the boundaries of ophthalmic innovation.. Your leadership will be crucial in shaping the future of eye care, from the earliest stages of product development through to clinical trials, ensuring that our groundbreaking Glaukos products are safe, effective, and meet stringent regulatory standards.. If you're ready to lead the next wave of innovation in eye health, this is your opportunity to make a profound impact.. 12+ years of relevant clinical research experience, preferably in ophthalmology and medical devices, with 9+ years of direct study management.. Proven leadership in managing multiple clinical trials, including CRA and vendor management, meeting milestones, and managing timelines.

The University of Cincinnati Cancer Center (UCCC) Clinical Trials Office is an institutional resource within the University of Cincinnati College of Medicine and UC Health that provides administrative, nursing, and data management support for cancer clinical trials conducted by UC Investigators.. Liaises and works efficiently in collaboration with the CTO Assistant Director and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.. Interacts daily with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO Assistant Director to ensure all protocol requirements are met.. Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification.. REQ: 96941 SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN SF:IHE Clinical Research Manager, UC Cancer Center Date: Oct 18, 2024 Location: Cincinnati, OH, US #job-location.