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regulatory affairs in Boston

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  1. 94530 Sr. Associate, Regulatory Affairs

    Job Description: Responsible for ex-US Clinical Trial Application (CTA) submissions to national competent authorities (to include initial submissions, amendments, notifications and report), the level of support to vary depending on whether a CRO or affiliate is performing the submission. Analysis of regulatory issues and guidelines related to clinical trials. Responsible for accuracy and content of submissions and communications with regulatory bodies. Responsible for supporting efforts to comply ...

  2. Sr. Regulatory Affairs Associate II

    We have a Contract opportunity with a prominent client for a Senior Associate II, Regulatory Affairs  in Cambridge, MA.   Description:   *Must possess exceptional communication skills (both written and verbal) *Will be required to communicate with all levels within the organization   Job Title: Senior Associate II, Regulatory Affairs  Responsible for ex-US Clinical Trial Application (CTA) submissions to national competent authorities (to include initial submissions, amendments, notifications ...

  3. Regulatory Affairs Project Manager

      ~~Hawkins Point Partners has an immediate need on its Cambridge, Massachusetts team for a Regulatory Affairs Manager with recent experience supporting FDA Clinical Trial Application (CTA) submissions. This person will ensure initial trial submissions, amendments, notifications and reports from internal and CRO or affiliate submissions.  Strong knowledge of the pharmaceutical clinical process along with analysis of regulatory issues and guidelines related to clinical trials is a core position ...

  4. Director of Regulatory Affairs-paid relo to Rochester, NY-bzs0877

      Role: Strategic planning and management for the execution of comprehensive programs related to regulatory clearances, controls, and the assurance of corporate compliance with applicable US and international medical device regulations and standards.   Responsibilities: •Create strategy and perform oversight for global commercialization and post-market regulatory activities. •Establish and implement regulatory policies and procedures. •Supervision of global Regulatory Affairs professionals to ...

  5. Director Marketing Regulatory Affairs

    A leading company in the pharmaceutical industry is currently seeking a Director of Marketing and Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:<br><br>1) Provide regulatory support and guidance to commercial, medical, legal and other internal customers for successful and compliant implementation of product-specific advertising and promotional communications<br>2) Establish regulatory objectives for compliance with ...

  6. Director of Regulatory Affairs

    A leading company in the pharmaceutical industry is currently seeking a Director of Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:<br><br>1) Ensure developing product regulatory strategy for assigned projects & products for registration, maintenance of business or life-cycle management<br>2) Liaise with regulatory counterparts to ensure regional requirements are incorporated into product approval<br>3) Develop a ...

  7. Director of Global Regulatory Affairs

    Our client is currently seeking a driven and ambitious Director of Global Regulatory Affairs to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.<br><br>1) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials<br>2) Develop strategies for regulatory approval and introduction of new products to market<br>3) Manage the process from development of regulatory strategies ...

  8. Regulatory Affairs Manager (medical devices)

      We are seeking an experienced, high caliber Regulatory Affairs Manager.  Working under broad supervision, the RA Manager has primary day-to-day management responsibility directly for assigned regulatory submissions and prepares, reviews, and manages submissions for domestic and/or worldwide regulatory approvals.  The RA Manager provides leadership and direction to regulatory submissions staff and regulatory strategy to other departments, including Development, Program Management, Marketing, ...

  9. Sr. International Regulatory Affairs Specialist

    Sr. International Regulatory Affairs Specialist Location: Braintree, MA Our client is a global medical device and healthcare services organization.  They are building out their International Regulatory Affairs team and need an experience associate!  This position is requiring an individual with a strong background in medical device regulatory affairs within the following regions:  Asia-Pacific (APAC), Latin America (LATAM) and Europe (EU). Job Description: The Sr. International Regulatory Affairs ...

  10. Manager, International Regulatory Affairs

    Manager, International Regulatory Affairs Location:  Braintree, MA Our client is a global medical device and healthcare services organization.  They are building out their International Regulatory Affairs team and need an experienced mentor to lead the group.  MUST have a strong background with medical device regulatory affairs in the following regions:  Asia-Pacific (APAC), Latin America (LATAM), Europe (EU). Job Description: Accountable to drive and complete all regulatory submission and ...

  11. Director of Regulatory Affairs-Med-Device hh

    Director of Regulatory Affairs-Med-Device Boston - MA Job Description The Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the regulatory functions. This position reports directly to the Sr. VP – Global Product Operations. This person manages Regulatory Affairs staff in addition to oversight responsibility for Regulatory consultants. This position coordinates departmental planning, manages multiple project teams and ...

  12. 3850092 – Regulatory Affairs Manager

      A scientific degree in an appropriate biomedical subject (e.g. Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc.). Advanced degree preferred. A minimum of 5 years work experience in Regulatory Affairs, preferably within the biologics/biotechnology area Extensive knowledge of respective national procedures and requirements         This position will require considerable teambuilding, cross divisional work, conference calls and emails. Therefore, the following skills are crucial:     ...