Regulatory Affairs Manager jobs in New York

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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CMC Regulatory Affairs Manager
  • Katalyst HealthCares & Life Sciences
  • Tarrytown, NY CONTRACTOR
  • Responsibilities

    • Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
    • Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes.
    • Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
    • Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
    • Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives.
    • Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
    • Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.

    Requirements

    • Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
    • 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
    • Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
    • Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
    • Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
    • Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
    • Detail-oriented mindset with a focus on quality, accuracy, and compliance.
    • Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
    • Regulatory Affairs Certification (RAC) is a plus.
  • 7 Days Ago

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Regulatory Affairs Senior Manager
  • Katalyst HealthCares & Life Sciences
  • Tarrytown, NY CONTRACTOR
  • Responsibilities US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Paten...
  • 8 Days Ago

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Manager, Regulatory Affairs Strategy
  • Regeneron
  • Tarrytown, NY FULL_TIME
  • The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics...
  • 8 Days Ago

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Regulatory Affairs Manager
  • 24 Seven Talent
  • New York, NY FULL_TIME
  • Our client is a leading beauty company that is looking for a new Regulatory Affairs Manager to join their team!About the RoleThe Regulatory Affairs Manager ensures regulatory compliance of the compani...
  • 1 Day Ago

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Manager, Regulatory Affairs Strategy
  • Regeneron Pharmaceuticals Inc.
  • Tarrytown, NY FULL_TIME
  • The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics...
  • 11 Days Ago

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Senior Manager, Regulatory Affairs
  • Taro Pharmaceuticals
  • Hawthorne, NY FULL_TIME
  • This position will serve as the company US Agent and a contact point between the FDA and Taro sites. Responsible to communicate with FDA for all regulatory issues/questions and provide regulatory guid...
  • 14 Days Ago

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Healthâ„¢
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/23/2024 12:00:00 AM

New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States. New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean. In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$147,607 to $208,201

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019