Remote Senior Regulatory Affair jobs
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SENIOR MANAGER, REGULATORY AFFAIRS - GENERAL MEDICINE
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...
| Company | Biospace |
|---|---|
| Address | Basking Ridge, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | yesterday See detail |
Senior Manager, Regulatory Affairs - General Medicine
Biospace
Basking Ridge, NJ
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...
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Senior Manager CMC Regulatory Affairs
Biospace
Basking Ridge, NJ
Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...
6 days ago seen See more...
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Director or Senior Director, Regulatory Affairs
Veranex, Inc.
San Jose, CA
$165,000 - $263,000 a year
Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...
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Senior Product Stewardship & Regulatory Affairs Specialist Job
Arkema
United, PA
Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...
2 weeks ago seen See more...
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Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology
Astrazeneca
Boston, MA
Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...
3 weeks ago seen See more...
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Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination
Biospace
North Chicago, IL
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...
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Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH
Abbott Laboratories
Lake Forest, IL
$72,700 - $145,300 a year
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...
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Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.
Johnson & Johnson
Santa Clara, CA
...
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Senior Regulatory Affairs Specialist
Iconma, Llc
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
2 months ago seen See more...
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Senior Regulatory Affairs Specialist
Axelon
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
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Senior Regulatory Affairs Specialist
Collabera
Saint Paul, MN
Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...
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Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
4 weeks ago seen See more...
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Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
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Manager, CMC Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...
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Associate Director, Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
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Senior Manager/Associate Director of Regulatory Affairs
Tempus
Chicago, IL
Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...
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Director Regulatory Affairs *Remote*
Providence
Beaverton, OR
Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...
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Senior Manager, Regulatory Affairs - Proliant Health & Biologicals
Lauridsen Group, Inc.
Ankeny, IA
Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...
2 months ago seen See more...
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Senior Associate of Regulatory Affairs, CMC
Meitheal Pharmaceuticals Inc
Chicago, IL
Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...
2 months ago seen See more...
Senior Manager Regional Regulatory Affairs
Biospace
King Of Prussia, PA
You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...
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Regulatory Affairs Senior Program Manager
Biospace
San Francisco, CA
6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...
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Regulatory Affairs Senior Consultant
Medenvoy Global Bv
Remote
From $100,000 a year
Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...
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Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs
Wells Fargo
Charlotte, NC
Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...
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