Senior Regulatory Affairs jobs
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DIRECTOR OR SENIOR DIRECTOR, REGULATORY AFFAIRS
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,...
| Company | Veranex, Inc. |
|---|---|
| Address | San Jose, CA |
| Category | Sales/marketing |
| Salary | $165,000 - $263,000 a year |
| Job type | Full-time |
| Date Posted | 24 hours ago See detail |
Director or Senior Director, Regulatory Affairs New
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,...
24 hours ago seen See more...
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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 days ago seen See more...
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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...
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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...
2 months ago seen See more...
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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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VP/Senior VP, Regulatory Affairs
Biospace
San Diego, CA
Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...
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Senior Regulatory Affairs, Study Start Up Specialist
Cti Clinical Trial Services Inc
Covington, KY
$73K - $92.5K a year
Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs. Compile/ oversee site Regulato...
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Senior Regulatory Affairs Advisor
Cook Device Solutions
Remote
$100,000 - $125,000 a year
Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...
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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...
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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 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...
3 weeks ago seen See more...
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Regulatory Affairs Specialist III
Boston Scientific
Maple Grove, MN
Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...
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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...
3 weeks ago seen See more...
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Senior Medical Scientist - Global Medical Affairs Oncology Solid Tumor Early Products
Biospace
Washington, DC
Contribute to the Global Medical strategy through deep understanding of medical practice Provide support for the development and achievement of the clinical development plan for the oncology products through strategic medical insi...
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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...
a month ago seen See more...
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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...
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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,...
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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...
2 months ago seen See more...
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Senior Manager, Regulatory Affairs Biocides - Remote
Steris
Alpharetta, GA
Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...
2 months ago seen See more...
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Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid)
Teva Pharmaceuticals
West Chester, PA
Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...
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Senior Director, Regulatory Affairs II
Teva Pharmaceuticals
West Chester, PA
Manage resources to support submission activities for responsible sites and oversees the coordination and delivery of major submissions to directly support the companies growth strategy. Build relationships with RA staff/authorin...
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Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Biospace
Washington, DC
To lead GRTs within Amgens GRAAS organization. To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes...
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Senior Associate Regulatory Affairs
Amgen
Washington, DC
Execute the international regulatory strategy and regulatory plans.. Prepare supportive documentation for regulatory deliverables.. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).. Suppo...
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Senior Associate Regulatory Affairs
Biospace
Washington, DC
Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...
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