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regulatory affairs in Chicago

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  1. Director of Pharmacy at Roseland Community Hospital – Chicago, IL

    Assure compliance with standards of practice of state and federal regulatory agencies; Including, but not limited to the Center for Medicare and Medicaid...

  2. Head, Global Regulatory Affairs Compliance at Takeda Pharmaceuticals

    Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs....

  3. Global Training Director at Takeda Pharmaceuticals

    Identify and prioritize therapeutic area and product training needs across Takeda’s Medical Affairs organization....

  4. Executive Medical Director - Medical Affairs, CNS at Takeda Pharmaceuticals

    Provide oversight medical review, direction, and sign off of promotional pieces processed to the DDMAC Regulatory Affairs committee....

  5. VP Global Medical Affairs Research and Global Publications at Takeda Pharmaceuticals

    Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies....

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    1. Manager-Regulatory Affairs (441189)

      OVERVIEW:Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Develop regulatory ...

    1. Executive Director, Centers of Clinical Development at PPD

      Delivers centralized monitoring to industry and regulatory standards. Interfaces with leaders in Project Management, Site Initiation and Activation, Clinical...

    1. 100729 - Manager – Regulatory Affairs

      Minimum requirements: · Regulatory Affairs Experience in pharmaceutical industry.· Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.· Prior management experience, with a demonstrated capability to lead and motivate staff is essential.· ...

    1. Technical Account Manager, SIEM Engineering at Optiv

      General understanding of compliance & regulatory concerns for all types of industries. Proactively review and discuss Client’s state of affairs, i.e. solution...

    1. Assistant General Counsel - Regulatory-1650008742

      Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. ...

    1. Technical Account Manager, SIEM Engineering at Fishnet Security

      General understanding of compliance & regulatory concerns for all types of industries. Proactively review and discuss Client’s state of affairs, i.e. solution...

    1. Assistant General Counsel - Regulatory -  1650008742

      Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine.We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. ...

    1. Clinical Data Standards Expert at Chiltern International

      Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to...

    1. Regulatory Specialist

      Ensure faultless compliance of recipes and labeling/renovation process.Assist Regulatory Affairs team with ingredient and formula reviews, label development and graphics reviews.Nutrition knowledge preferred

    1. Mgr of Global Reg Affairs 1 at PRA Health Sciences

      May participates in project teams, leads specific regulatory tasks, and serves as regulatory lead on multiple projects....

    1. Assistant Director, Health Systems Marketing - 1650019459

      Description:               Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is ...

    1. Dir of Global Reg Affairs 2 at PRA Health Sciences

      Provides functional management to the regulatory affairs department staff. Acts as Global Regulatory Affairs Program Oversight on assigned projects....

    1. Associate Director / Senior Manager Regulatory Affairs, US Labeling

       Fortune 500 Pharmaceutical company is looking for an Associate Director / Senior Manager Regulatory Affairs, US Labeling for a long term contract. If qualified please send your resume and rate requirements- The terms and contract rate are very good for the right person .We are an established consulting firm that is an approved vendor and supplier to the client. Thank you.Recruiter Notes ...

    1. Account Executive at Tuv America

      TÜV SÜD Canada Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has immediate openings at our facility in Laval,...

    1. Clinical Research Associate

      Primary Job FunctionResponsible for the review, approval, start-up, maintenance and close-out procedures for IIS proposals and Affiliate-sponsored studies (i.e. PMOS)Responsible for the overall tracking and maintenance of the Insights and IMPACT Databases, reporting of study information and metricsAware of both internal and external business environments and their impact on studies. Escalates ...

    1. Medical Advisor (Turkey) at BTG Careers

      With involvement in clinical plus nonclinical and/or CMC activities or regulatory affairs) ideally in an international matrix environment....

    1. Sales Manager - Medical Device

      Manager - Medical Devices Industry innovator in leading development and production of medical devices seeks a Business Development - Sr. Product Manager to help lead marketing efforts for the company. The Account Manager will report to VP of Marketing and will work closely with Engineering, Sales, Clinical, Customer Advocacy, Quality Assurance, Operations and Regulatory Affairs personnel. ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Director, Project Management - Medical Affairs Research Operations (Late Phase Trials) at PPD

      Knowledge of regulatory guidelines and Directives. The Director, Project Management works effectively across multiple divisions to direct the delivery of...

    1. Medical/ Safety Reviewer (440714)

      OVERVIEW:Medical review - involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing,QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical ...

    1. Sr. Vice President, Clinical Operations at Worldwide Clinical Trials

      Manages a group of global Clinical Research professionals to deliver high quality, timely and efficient clinical trial support to our sponsors in the areas of...

    1. Regulatory Affairs Manager - Biopharmaceutical Clinical Development

      Seeking individual with Doctorate level degree and 10+ years experience in clinical development regulatory affairs. Requires relocation to facility near Stanford University in Northern California. Required Track Record: *** Preparation and management of successful IND & BLA submissions in US. *** Liaising with FDA and internal clinical development teams to achieve successful ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    2. Director of Regulatory Affairs

      The Director of Technical & Regulatory Services manages and develops the objectives and strategies for the development, implementation and integrity of the Company’s Corporate Quality Document Management System. The focus will be on providing accurate, comprehensive and up-to-date information concerning the products that are manufactured and sold. Key stakeholders for this role include the ...

    3. CMC Manager /Director - Pharmaceutical

       Fortune 500 Pharmaceutical company is looking for an experienced CMC Manager, for a long term contract. If qualified please send your resume and rate requirements- The terms and contract rate are very good.We are an established consulting firm that is an approved vendor and supplier to the client.Thank you. Notes for Ideal Candidate:8 + years pharmaceutical Regulatory CMC experience.Computer ...

    4. Medical Science Liaison, Dementia/Diagnostic Imaging

      Emerging leader in the field of molecular imaging has a new full time opportunity for a Field Based Medical Director/MSL specializing in the area of Dementia/Diagnostic Imaging to cover the Mid West territory: WI, IA, IL, IN, MO, OK, TX. Ideal candidate should live in the Chicago area. Company offers excellent compensation and benefits package!Roles, and key responsibility :Provide scientific ...

    5. Senior BRS Information Manager - 1650013020-01

      Description:Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine.We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is ...

    6. RN with Pharma experience for Safety Monitor (EDC,AEGIS)

      Let me know if avail /interested. Thank you, Denisesend a word format resume to [email removed]847 995-1300 x23Medical Reviewer/Safety Reviewer - B North suburbs of Chicago10933 32-36.00 AN HOUR W2 CONTRACT 1YEAR+Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events ...

    7. Medical Science Liaison - Ophthalmology (Midwest)

      Novartis is recruiting for a Medical Science Liaison (MSL) to cover the Midwestern US Region. Preferred area of residence is within the area of coverage: Chicago, IL; Minneapolis, MN; IAA global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. This pipeline consists of innovative medicines brought to life by diverse, talented, performance ...

    8. Associate Director, RWI Statistical Methodologist - 1650035167

      Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. ...

    9. Associate General Counsel Regulatory - 1650004629

      Description        Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. ...

    10. Pharmaceutical R&D Management Consulting Senior Manager (#922) - Perm

      Locations: Philadelphia, New York/ Florham Park, Chicago, BostonClient is only looking for Midwest/East Coast candidatesJoin CLIENT and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose CLIENT, ...

      1. HOTEL OPERATIONS SUPERVISOR at Ameristar Casino Hotel

        Maintains an appropriate level of community affairs involvement. Adheres to, interpret, support, and explain established company policies and procedures as well...

      2. Thought Leader Liaison (Oncology) - Chicago, IL at Novocure

        Work within the Novocure regulatory and legal compliance guidelines. The TLL will collaborate with cross functional field based and home office teams, including...

      3. Thought Leader Liaison - Dermatology (Chicago, IL) at Regeneron

        Work within label, and regulatory and legal compliance guidelines. A TLL will work cross-functionally with home-office based colleagues in Marketing, Medical...

      4. Sr. Manager / Director, Scientific Affairs at MicroPort Orthopedics

        The Scientific Affairs department also provides the Clinical perspective when interfacing with multiple departments including Regulatory Affairs, Product...

      5. Medical Science Liaison/Sr. MSL Women's Cancer I/O - Northern CA/Reno, NV at AstraZeneca

        Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...