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Regulatory Affair Associate jobs

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SR. MANAGER, REGULATORY AFFAIRS CMC (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...

CompanyPtc Therapeutics
AddressRemote
CategoryInformation Technology
Job typeFull-time
Date Posted 2 months ago See detail

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

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...

2 months ago seen See more...

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 (...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Morristown, NJ

$113K - $143K a year

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in D...

2 months ago seen See more...

Associate Director Regulatory Labeling

Acadia Pharmaceuticals Inc.

San Diego, CA

Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management. Support implementat...

4 weeks ago seen See more...

Associate Director of Multicultural & International Student Affairs

Simpson College

Indianola, IA

Developing, planning and implementing campus-wide diversity related resources, services and programs for multicultural, international and marginalized students to ensure student success and belonging. Developing, planning and impl...

4 weeks ago seen See more...

Associate Director, Field Medical Affairs- Hematology (Chicago area)

Biospace

Chicago, IL

Want to be a part of a pre-launch stage Field Medical team a with potential for multiple launches.. Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt ap...

4 weeks ago seen See more...

Associate Director, US Medical Advertising and Promotions Regulatory (GI)

Biospace

Lexington, MA

Mentor and develop staff. Supervise, trains and provides technical and regulatory guidance to staff. You will serve as the chair of promotional review meetings, and assist commercial with the planning and prioritization of propose...

4 weeks ago seen See more...

Sr. Associate Provost & Sr. Assoc. VP Academic Affairs

Texas Southern University

Houston, TX

Represents the Provost and Sr. Vice President for Academic Affairs as needed. Work collaboratively with the Directors of the Office of Institutional Research, the Office of Research and Sponsored Programs, the Office of Enrollment...

4 weeks ago seen See more...

Social Work Associate Dean of Academic Affairs

University Of Pittsburgh

Pittsburgh, PA

United States, Pennsylvania, Pittsburgh

This is an exciting time to join the school, with focused critical attention to ensuring a more anti-racist/anti-oppressive curriculum and learning environment across all programs. We also seek someone who shares our commitment to...

4 weeks ago seen See more...

Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience

Biospace

Remote

As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...

4 weeks ago seen See more...

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There are open Regulatory Affair Associate jobs in several cities including Cincinnati, Plainsboro, Boston, Parsippany, Hoschton, Princeton, Seattle, Piscataway, Totowa, Englewood Cliffs, Summit, Boonton, Portland, South Plainfield, Houston,

What companies are hiring for Regulatory Affair Associate jobs?

The top companies hiring now for Regulatory Affair Associate jobs are Actalent, Baylor College of Medicine, Capleo Global, ClinChoice Inc, Danaher, Epitope Diagnostics, Inc., Katalyst Healthcares & Life Sciences, Meitheal Pharmaceuticals Inc, Pyramid Consulting, Inc., Pyramid Consulting, Inc., Teva Pharmaceuticals, Therapeutics Inc., Zobility,

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