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DIRECTOR / SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle.....


Vice President, Regulatory Affairs San Francisco Bay Area Our client is seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance drug development program. The successful candidate will bring strong leadership abilities to oversee the Regulatory Affairs team, a successful history of effectively leading IND and NDA filings through approval, and interacting effectively with the FDA and other foreign regulatory bodies. This position....

- San Francisco Bay Area, CA

DIRECTOR, REGULATORY AFFAIRS – CMCSan Francisco Bay Area Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout....

- Hopkinsville, KY

Our Food Safety Manager is responsible for managing our in-house Micro-Lab and implementing and managing process control systems and preventative actions in the food safety area. You will manage all HACCP and Regulatory compliance issues at this processing site. Client company cannot sponsor or transfer Visa's at this time. Qualifications:Bachelor’s degree in Food Science, Microbiology, Chemistry, Biology. An advanced degree is preferred.A minimum of two years’ experience in Food Safety....

- Winston-Salem, NC

Join a global leader as a Eco-Toxicologist responsible for conducting quantitative environmental risk assessments for agrichemical and fertilizer products and traits in North America. You will provide technical advice on study designs for regulatory and research oriented studies as well as advice to support new and existing registrations of client products and traits. --- Work closely with regional/global regulatory and product safety teams as well as other functional teams to produce risk....

- Any US State

Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....

- Pleasanton, CA

Our large drug/device combo client in Irvine, CA needs a temporary Regulatory Affairs Associate. This contract is estimated to last 12 weeks. This person will coordinate most aspects of company regulatory activities and may interface with domestic and international health authorities. Qualifications: - BS or BA degree, 1-3 years of experience in regulatory affairs. - Experience in a company start-up environment, preferably in medical devices or combination products. - Knowledge of FDA, CA-FDB,

- Seattle or Tacoma, WA

Medical Director – Behavioral Health – Seattle Area New role in the organization will collaborate with the VP of Medical Affairs to direct and coordinate the physician component of the utilization management functions for the local health plan, with emphasis on the behavioral component of the integrated care programs. · Provides medical leadership for utilization management activities and medical review activities pertaining to utilization review, quality assurance, medical review of complex,....


Rates and Regulatory Affairs Analyst- Revenue Recovery Company Information Our client has been providing clean, safe and reliable natural gas for more than 130 years and have a combined workforce of almost 1,300 employees. They have been committed partners and leaders in the natural gas industry, currently providing reliable energy to more than 700,000 customers. Their vision is to help move forward by serving their customers well, creating jobs and supporting economic development in the....


Are you a Psychiatrist who is ready for a change? Outstanding opportunity for a Practicing Board Certified Psychiatrist who is interested in working a Utilization Review role in the Tacoma/ Seattle, WA area. It is required you have a Washington State license that is in good standing. It is a plus if you have Medical Director experience or even experience working with a health plan company. There is the possibility to work remote. This opportunity come with a 20% performance bonus structure and


Are you a BC MD or DO BC by an Approved ABMS Board preferably in a primary care specialty (Internal Medicine, OB, Med/Peds, Family Practice Pediatrics or Emergency Medicine) or other specialty (and familiar with Medicare patients) who is ready for a change? This is a 32 hour a week position with the expectation you will be involved in some clinical activity. This is and outstanding opportunity for someone who is interested in working a Utilization Review role in the Columbus, OH region. It is....


This is a key position that will have product development oversight responsibility for Design Control as the product moves through the development stages to commercialization. Key liaison between Product Development, Quality Engineering, and Regulatory Affairs. Maintain focus on VOC requirements as defined by Marketing. Required Background & Experience:MEDICAL DEVICE PRODUCT DEVELOPMENT EXPERIENCEBS degree in a technical discipline, preferably engineering. Advanced degree is a plus.Strong....

- Seattle OR San Fran, Cali, WA

Top tier Pharmaceutical company in Seattle, WA is expanding They are opening new office as well i nthe San Francisco Bay area of Califronia- this role can be located in either location Full benefits-medical/health, 401k and match, stock, LTis and STis...many progressive benefits...competitive compensation and bonus and more... Full relocation to either area The Sr. Director, Clinical Operations Program Management will be responsible for leading all aspects of clinical operations within the....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....

- Any US State

Validation Manager To manage all validation activities at the plant. This includes but is not limited to facility, equipment, cleaning, computer and process validation. This position will lead the site to ensure compliance to all applicable regulations and requirements. Ensures implementation of compliant validation master plan for the site and ensures all activities within the master plan are planned and executed. Writes, reviews and executes any required validation protocols to ensure....


Relocation assistance to Tulsa, OK approved for this position. Key requirements for candidates: - Experience in New Product Development quality aspects for medical devices - Able to deal at high level across technologies that might be out of his core competencies - Awareness of international medical standards and regulations - Risk management for medical device (14971) - Ability to work in great autonomy since remote from the rest of the team - Engaging and communicating effectively. Other....


RETAINED SEARCH ASSIGNMENT Quality Assurance Validation, ManagerVMP – Validation to include: Facility, Utilities, Equipment, Computer, etc.QA Validation MgrMUST have Bio Pharma experienceManage Validation, Write Protocols,Manage EquipmentProject Manager for all Validation ProjectsResponsible that Validations are prepared and executedDesign Validation studies; USA & EUExecute CAPA action plan9CFRDegree BS a Science or relatedPrefer 2+ yrs supervision & experience designing and....


Are you a BC MD or DO BC by an Approved ABMS Board preferably in a primary care specialty (Internal Medicine, Med/Peds, Family Practice, Psychiatry, Pediatrics or Emergency Medicine) or other specialty (and familiar with Medicare patients) who is ready for a change? This is and outstanding opportunity for someone who is interested in working a Utilization Review role in the Las Vegas region. It is required you have a Nevada license that is in good standing. It is a plus if you have Medical....

- Cincinnati, OH

Job Description: Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management. The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving....


Senior Regulatory Affairs Specialist (Medical Device) Newark, DE (Relocation Assistance Provided) Competitive Base Salary, Bonus 10%, 6 401K Match, Full Benefits, 4 weeks PTO We have a newly created opening for a Senior Regulatory Affairs Specialist position with a longstanding client; multi-billion global medical instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that....

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