Regulatory Affairs Manager jobs
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CMC 2 MANAGER- REGULATORY AFFAIRS
Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in...
| Company | Raise In Partnership With Genpact |
|---|---|
| Address | United States |
| Category | Information Technology |
| Salary | $103K - $131K a year |
| Job type | Temporary | Contract |
| Date Posted | 2 months ago See detail |
CMC 2 Manager- Regulatory Affairs
Raise In Partnership With Genpact
United States
$103K - $131K a year
Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in...
2 months ago seen See more...
Manager, Regulatory Affairs - Devices
Allergan Aesthetics
Irvine, CA
$125K - $158K a year
Represents US Regulatory in project teams. Develops US regulatory filing strategy, with input from supervisor. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives. Work...
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Manager, Regulatory Affairs
Rion Inc
Rochester, MN
From $113,018 a year
Bachelors in Science / Masters (Preferred). Regulatory Affairs Experience: Minimum 5 years. Assist in the development, review, and approval of key documents, including abstracts, presentations, protocols for IND and BLA submission...
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Senior Manager, Regulatory Affairs, CMC
Beigene
Remote
$133,400 - $178,400 a year
Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...
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Associate Manager of North America Regulatory Affairs
International Flavors & Fragrances
Palo Alto, CA
$105.60 - $118.80 an hour
Responsible for overall management of the Animal Nutrition product portfolio. Draft submissions such as US feed GRAS, US AAFCO submissions, and Canadian feed approvals. Serve as the main point of contact for the Animal Nutrition b...
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Solta Senior Manager, Regulatory Affairs
Solta Medical
Bothell, WA
$120,000 - $180,000 a year
Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product p...
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Sr. Manager, Regulatory Affairs CMC (Remote)
Ptc Therapeutics
Remote
Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...
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Regulatory Affairs Project Manager
Endologix
Irvine, CA
$104,000 - $165,000 a year
Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory re...
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Manager, Regulatory Affairs
Ascendis Pharma
Palo Alto, CA
$140,000 - $150,000 a year
Today, were advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful diffe...
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Regional Manager of Quality & Regulatory Affairs
Alaska Dialysis
Alaska, United States
$81.7K - $103K a year
Responsible for overseeing regulatory and growth perspective in accordance with Company goals. Assist in clinical operational development and transition of new or acquired clinic(s) as needed or requested. Assess and integrate cli...
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Group Manager, Regulatory Affairs
Globus Medical, Inc.
Audubon, PA
$110K - $139K a year
Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval...
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Senior Manager, Regulatory Affairs - Product Development
Arthrex
Naples, FL
$114K - $145K a year
Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements. Lead assigned team(s) in establishing short-term and...
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Manager, Regulatory Affairs CMC
Takeda Pharmaceutical
Boston, MA
$133,000 - $209,000 a year
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...
2 months ago seen See more...
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Manager - Regulatory Affairs
Jtm Food Group
Harrison, OH
$95.6K - $121K a year
Top Work Place Winner. Weekly Pay. Free Meal Buffet, Discount on JTM Products. Free Uniforms, Shoe Allowance. Free Gym Membership, Free Health Screenings. Full Medical Benefits. 401K/Profit Sharing. Generous PTO. Bonus Potential (...
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Regulatory Affairs Director: State Prog Admin Manager Prin
State Of Minnesota
Saint Paul, MN
$46.36 - $66.49 an hour
Who May Apply: Open to all qualified job seekers Date Posted: 03/20/2024 Closing Date: 04/09/2024 Hiring Agency/Seniority Unit: Commerce Dept / Commerce-Managerial Division/Unit: Energy Resources / Office of Regulatory Affairs Day...
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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...
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Regulatory Manager
Rwe
San Diego, CA
Identify wholesale market opportunities within the organized and unrestructured regions of the US Western Interconnect. Develop and execute regulatory advocacy strategies designed to represent the commercial interests of RWECE. Ma...
3 days ago seen See more...
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VP/TA Head, General Medicine - Global Regulatory Affairs
Merck
Rahway, NJ
Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...
5 days ago seen See more...
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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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Regulatory Affairs Intern (Onsite)-Summer-Fall 2024
Becton Dickinson
Covington, GA
Assist with product submissions and regulatory assessments. Ensure compliance with all relevant regulatory requirements. Improve departmental procedures and processes. Assist with regulatory assessments for design change and non-d...
6 days ago seen See more...
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Senior Manager Regulatory (Boise, ID or Loveland, CO)
Simplot
Boise, ID
Medical, dental, vision coverage. 401(k) savings plan. Paid Family Building Leave. Generous Paid Time Off - Eligible employees may accrue up to 160 hours in year 1. 10 Paid Holidays. Relocation Assistance Program (where applicable...
3 days ago seen See more...
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Regulatory Policy Manager - Credit Valuation Adjustment
Hsbc
New York, NY
Track new policy developments and formulate HSBCs regulatory capital policies accordingly, providing detailed, actionable guidance, distributed to a wide range of stakeholders. The US GRPA team is responsible for monitoring new d...
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Head of Regulatory Affairs Policy & Regulatory Intelligence
Biospace
Thousand Oaks, CA
Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and Regulatory Intelligence professionals, ensuring they are appropriately qua...
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SVP - Internal Audit Senior Manager - Regulatory Capital Reporting - Hybrid
Citi Private Bank
Lorida, FL
Deliver audit reports, Internal Audit and Regulatory issue validation and business monitoring and governance committee reports in the area of Regulatory Capital Reporting. Lead reviews for all types of reviews, including the most...
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Manager, Risk & Regulatory Advisory
Morgan Franklin
California, United States
Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist c...
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Senior Manager, Risk & Regulatory Advisory
Morgan Franklin
Texas, United States
Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist...
5 days ago seen See more...
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Manager, Risk & Regulatory Advisory
Morgan Franklin
Nashville, TN
Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist c...
5 days ago seen See more...
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Manager, Risk & Regulatory Advisory
Morgan Franklin
Texas, United States
Work with emerging growth companies and established enterprises (bothpubliclytraded and privately held) on a wide variety of projects including Sarbanes-Oxley ("SOX") readiness and compliance, internal audit, and ERM.. Assist c...
5 days ago seen See more...
- View all - jobs in Texas State
Director of Clinical Affairs Program Management
Biomérieux
Salt Lake City, UT
A family-owned company, bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve publi...
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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...
2 weeks ago seen See more...
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