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REGULATORY AFFAIRS MANAGER - BIOLOGICS

Bachelors degree required, Masters Degree preferred, in Biology, Microbiology, or similar life sciences. 10-14 years relevant regulatory experience in either the veterinary biopharmaceutical or biologicals industry. More than 5...

CompanyHuvepharma, Inc.
AddressLincoln, NE
CategoryInformation Technology
Salary$113,000 - $135,000 a year
Job typeFull-time
Date Posted a month ago See detail

Regulatory Affairs Manager - Biologics

Huvepharma, Inc.

Lincoln, NE

$113,000 - $135,000 a year

Bachelors degree required, Masters Degree preferred, in Biology, Microbiology, or similar life sciences. 10-14 years relevant regulatory experience in either the veterinary biopharmaceutical or biologicals industry. More than 5...

a month ago seen See more...

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 Specialist

Cybotic System

Ithaca, NY

Up to $80,000 a year

Remain current on all applicable regulatory guidances that impact the companys ability to legally market medical devices around the world and assist in updating relevant SOPs based on those changes. Remain current with all mandat...

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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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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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Sr. Regulatory Affairs Specialist

Organ Recovery Systems, Inc.

Itasca, IL

From $90,000 a year

401(k). 401(k) matching. Dental insurance. Employee assistance program. Flexible schedule. Flexible spending account. Health insurance. Life insurance. Paid time off. Professional development assistance. Tuition reimbursement. Vis...

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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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Sr. Regulatory Affairs Manager

Mass General Brigham Health Plan

Somerville, MA

$129K - $163K a year

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on...

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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...

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Regulatory Affairs Manager

Skylls Solutions

Colchester, IL

$71,562.33 - $90,000.00 a year

401(k). Dental insurance. Health insurance. Paid time off. Vision insurance. Monday to Friday. Candidate Email:-. Regulatory Affairs Manager: 4 years (Required). financial accounting: 4 years (Required). Colchester, IL 62326: Relo...

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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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Data Analyst - Regulatory Affairs

Adecco

Morris Plains, NJ

$ 32 - $ 34 / Hour

A Data Analyst - Regulatory Affairs position based out of Morris Plains, NJ is now available through Adecco Medical and Science. Responsibilities: Review formulas for Research and Development. Familiar with SAP Collaborate wit...

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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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Regulatory Affairs Sr Manager (Medical Device)

Connexion Systems & Engineering, Inc.

Westford, MA

Responsible for the oversight of Regulatory Affairs as directed. Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of in...

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Director of Transmission Policy & Regulatory Affairs - East Coast

Equinor

Boston, MA

Lead Transmission Policy and regulatory efforts related to large-scale renewable and energy storage development across eastern region. Work in coordination with East CoastPolicy & Regulatory Lead to integrate actionable transmiss...

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VP of Quality and Regulatory Affairs

Oxenham Group Llc

Woburn, MA

Develop and implement plans to ensure product product and market approval in various regions. Prepare and submit all regulatory filings. Responsible for regulatory compliance ensuring local and international regulations and standa...

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Mgr Regulatory Affairs

Elevance Health

San Juan, PR

Oversees preparation and submission of regulatory filings, including license applications and renewals, data reports, and material change notifications. Supports market conduct exam activities. May interact with state regulators w...

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Manager, Regulatory Affairs - Biosimilars

Teva Pharmaceuticals

West Chester, PA

The Manager is responsible for supporting the Regulatory Affairs strategic vision and regulatory leadership in defining the global regulatory strategy for biosimilar projects. The Manager is accountable to support the Global Regul...

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Associate Director / Director, Regulatory Affairs (Generic Medicines)

Cnam - Auditeurs - Accueil

Princeton, NJ

This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...

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Associate Director, Regulatory Affairs

Bausch + Lomb

Bridgewater, NJ

Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...

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Associate Manager, Regulatory Affairs

Kenvue

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

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Associate Manager, Regulatory Affairs

Johnson & Johnson Consumer Inc.

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

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Associate Director, Regulatory Affairs

Johnson And Johnson

Somerville, NJ

Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....

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Attorney Government and Regulatory Affairs

Malamut & Associates

Cherry Hill, NJ

401(k). Competitive salary. Health insurance. Paid time off. At least 1-3 years experience in direct handling of public sector clients. Juris Doctor Degree. Admission to New Jersey Bar. Currently in Good Standing with the New Jers...

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Associate Director, US Regulatory Affairs Strategy

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

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Regulatory Lead and Compliance Officer - USA (Remote)

Gocardless

Texas City, TX

Developing a comprehensive regulatory strategy for the US and Canada that is fit for GoCardless' current business and strategic objectives. Obtaining (if needed) and maintaining all requisite licences and authorizations (including...

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