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Regulatory Affair Lead jobs

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SENIOR ASSOCIATE REGULATORY AFFAIRS

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...

CompanyAmgen
AddressWashington, DC
CategoryInformation Technology
Date Posted a month ago See detail

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...

a month ago seen See more...

Regulatory Affairs Specialist II

Bausch + Lomb

Remote

$65,000 - $95,000 a year

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...

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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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Director, Regulatory Affairs Advisor & Liaison

Capital One

Virginia, United States

Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...

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Associate Director, Regulatory Affairs

American Cybersystems

San Rafael, CA

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022). ClearlyRated Client Diamond Award Winner (2020). One of the Largest Certified MBE Companies in the NMSDC Network...

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Senior Counsel. Global Regulatory Affairs

Visa

New York, NY

$201,500 - $262,000 a year

10+ years of relevant work experience with a Bachelors degree and J.D. Admitted to practice law in the United States and in good standing Strong academic credentials Excellent verbal and written communication skills Strong prefer...

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Export Compliance and Regulatory Affairs Manager

Lightpath Technologies

Orlando, FL

$84.7K - $107K a year

Paid vacation with option to rollover vacation hours and sell hours back to company for payout at full rate. Paid sick time. 10 paid company holidays Employee Stock Purchase Program Employer Paid Life Insurance, Personal Accident...

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Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Minnesota, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

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Manager, Regulatory Affairs

Bausch + Lomb

Remote

$90,000 - $130,000 a year

BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. to analyze impact on Company produc...

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Regulatory Affairs Manager

Pramand Llc

Bedford, MA

$97.2K - $123K a year

Regulatory Strategy Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization. Regula...

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Regulatory Affairs Associate Manager

Comtec

Remote

$35 - $43 an hour

Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations. Participate in validation of marketing campaigns and review of associated ma...

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Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

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Regulatory Affairs Manager

Sonablate Corp.

Indianapolis, IN

$110,000 - $120,000 a year

Develop and implement regulatory strategies to support domestic and global expansion efforts. Stay current on new and emerging compliance procedures and regulatory enforcement trends/actions. Track regulatory updates with emerging...

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Regulatory Affairs Manager

Siga Technologies, Inc.

Corvallis, OR

$115,000 - $125,000 a year

401(k). Dental insurance. Employee assistance program. Employee discount. Flexible spending account. Health insurance. Health savings account. Life insurance. Paid time off. Parental leave. Professional development assistance. Ref...

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SENIOR MANAGER REGULATORY AFFAIRS

Tk-Chain Llc

Princeton, NJ

$80,000 - $170,000 a year

Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...

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Regulatory Affairs Manager II

Bio-Rad Laboratories, Inc.

Irvine, CA

$149,000 - $204,800 a year

Advise site-based teams of appropriate actions in response to identified product compliance requirements. Lead QSD Regulatory Affairs team to meet business needs for product premarket approvals, clearances, and registrations neede...

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Manager, Regulatory Affairs

Immunomic Therapeutics, Inc.

Rockville, MD

$140,000 - $160,000 a year

Assists in the development of regulatory strategies and their execution. Coordinates the preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol...

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Regulatory Affairs Manager

Blueroot Health

United States

$111K - $140K a year

Oversight for coordination and execution of regulatory requirements (as defined under DSHE, NLEA, Medical Foods and Medical Devices) and procedures, ensuring full compliance across all brands of the Company. Management coordinatio...

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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...

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Regulatory Affairs Manager

Immune Deficiency Foundation

Washington, DC

$65,000 - $75,000 a year

Juris Doctorate or Masters degree in Public Policy, Public Administration, Political Science or related field desirable or equivalent Experience. Experience working within a governmental agency focused on health or for a patient...

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Jr Regulatory Affairs Associate

Codetru

Lake Forest, IL

$22 - $26 an hour

401(k). Dental insurance. Health insurance. Paid time off. Vision insurance. 8 hour shift. Medical device or Pharma: 1 year (Required). Lake Forest, IL 60045: Relocate before starting work (Required)....

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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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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California (Hybrid)

Beautyhealth

Long Beach, CA

$130,000 - $150,000 a year

Lead all Regulatory Affairs projects to ensure compliance with all international, federal, state, and local facility/product registration, licensing, and reporting requirements for cosmetics and medical devices. Support in managin...

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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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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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Regulatory Affairs Manager

Aesku Inc.

Des Plaines, IL

$93.6K - $118K a year

Design studies with input from marketing and R&D, and (as needed) regulatory consultants, minimizing samples and tests required. Coordinate with sample vendors and internal trial sites to procure, store, and manage trial samples i...

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Sr. Director, Regulatory Affairs Strategy

Taiho Oncology, Inc.

Pleasanton, CA

$240,000 - $283,000 a year

Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence assessments, and compliance remediations for Taiho Oncology, Inc., (TOI), projects including exploratory development an...

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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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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...

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