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Regulatory affairs Jobs in Philadelphia, PA

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Regulatory affairs • philadelphia pa

Last updated: 1 day ago

Regulatory Affairs Manager

stonhardMaple Shade, NJ, United States
Full-time

Responsible for managing Stonhard's global regulatory affairs, product stewardship, product safety, Safety Data Sheet (SDS) authoring and management, transportation compliance, and contractor quali... Show more

Senior Director State Govt Relations and Regulatory Affairs

pennsylvania medicinePhiladelphia, PA, United States
Full-time

Senior Director State Govt Relations and Regulatory Affairs.Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, ... Show more

Director, Regulatory Affairs, Ex-US

larimar therapeuticsPhiladelphia, PA, United States
Full-time

Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technolo... Show more

Attorney Government and Regulatory Affairs

malamut associatesCherry Hill, NJ, US
$80,000.00–$185,000.00 yearly
Full-time

All experience levels welcome to apply.Malamut Law is a client-focused law firm driven by Integrity, Compassion, and Commitment.With extensive experience, we deliver positive results for our client... Show more

Regulatory Operations Supervisor

calciumPhiladelphia, PA, US
Full-time
Quick Apply

The Regulatory Operations Supervisor manages the day-to-day execution of regulatory submissions.This role ensures submission materials are accurate, properly formatted, fully annotated, and deliver... Show more

Regulatory Affairs Coordinator

actalentCamden, NJ, United States
$70,000.00–$100,000.00 yearly
Permanent

Regulatory Affairs Coordinator.Schedule: 4 days onsite and 1 day remote.We are seeking a detail-oriented Regulatory Coordinator to support a growing Clinical Research team.This individual will play... Show more

Manager, Regulatory Affairs CMC

gilead sciencesPhiladelphia, PA, United States
$133,195.00–$172,370.00 yearly
Full-time

Kite Manager, Regulatory Affairs CMC.We're here for one reason and one reason only to cure cancer.Every moment is dedicated to developing treatments and every action moves us one step closer to ou... Show more

Associate, Regulatory Operations

publicis healthPhiladelphia, PA, United States
$19.37 hourly
Full-time

Digitas Health Job Opportunity.Digitas Health is the modern creative agency that takes on the biggest moments in healthcare, raising the standard of creative, and connecting people, partners, and i... Show more

Freelance Business Affairs Manager

publicis groupe holdings b vPhiladelphia, PA, United States
$35.53–$51.09 hourly
Full-time

Freelance Business Affairs Manager.Digitas Health is the Agency of Now: the first global connected-health agency, purpose-built for marketing today.Digitas Health specializes in helping health bran... Show more

Manager, Regulatory Affairs CMC

gileadPhiladelphia, PA, United States
$133,195.00–$172,370.00 yearly
Full-time

Kite Manager, Regulatory Affairs CMC.We're here for one reason and one reason only to cure cancer.Every moment is dedicated to developing treatments and every action moves us one step closer to ou... Show more

Regulatory Product Analyst

pennsylvania lumbermens mutual insurancePhiladelphia, PA, United States
Full-time

The Product Analyst supports the development of the company's product features, underwriting compliance, and competitive position.This position assists with existing product maintenance, new produc... Show more

Principal Regulatory Scientist

exponentPhiladelphia, PA, United States
Full-time

Principal Regulatory Scientist.Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients' most profoundly unique, unpreced... Show more

Senior Manager, Clinical Quality

larimar therapeuticsPhiladelphia, Pennsylvania, United States, 19102
Full-time
Quick Apply

Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential prote... Show more

 • Promoted

Manager, Global Medical Affairs

ssi peoplePhiladelphia/ Pennsylvania
Full-time

Manager, Global Medical Affairs.Philadelphia, Pennsylvania (On-Site).We are supporting an opportunity for a detail-oriented and collaborative professional to help manage global Investigator Sponsor... Show more

Associate, Regulatory Operations

mslgroupPhiladelphia, PA, United States
$19.37 hourly
Full-time

Digitas Health Job Opportunity.Digitas Health is the modern creative agency that takes on the biggest moments in healthcare, raising the standard of creative, and connecting people, partners, and i... Show more

Associate, Regulatory Operations

digitas north americaPhiladelphia, PA, United States
Full-time

Digitas Health Job Opportunity.Digitas Health is the modern creative agency that takes on the biggest moments in healthcare, raising the standard of creative, and connecting people, partners, and i... Show more

Associate Medical Affairs Manager

scope groupCamden, NJ, United States
Full-time

Associate Medical Affairs Manager.Working as part of the Medical Affairs department, the Associate Manager, Medical Affairs is an individual contributor role supporting delivery of the US medical s... Show more

Senior Associate, Regulatory Operations

prodigious worldwidePhiladelphia, PA, United States
Full-time

Senior Associate, Regulatory Operations.Digitas Health is the modern creative agency that takes on the biggest moments in healthcare, raises the standard of creative, and connects people, partners,... Show more

Regulatory Affairs Expert - Remote

yo ai labsPhiladelphia, Pennsylvania, USA
Remote
Full-time
Quick Apply

AI-driven healthcare projects by reviewing and evaluating regulatory documentation.The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying incons... Show more

Director, Regulatory Affairs & Licensing - Nuclear

holtec internationalCamden, NJ, United States
Full-time

Director, Regulatory Affairs & Licensing - Nuclear.Requisition ID: 1433 Location: Camden, NJ, US Job Family Function: Leadership Department: Licensing & Regulatory Affairs Division: Corporate Engin... Show more

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Regulatory Affairs Manager

Regulatory Affairs Manager

stonhardMaple Shade, NJ, United States
25 days ago
Job type
  • Full-time
Job description

Job Title

Responsible for managing Stonhard's global regulatory affairs, product stewardship, product safety, Safety Data Sheet (SDS) authoring and management, transportation compliance, and contractor qualification programs to ensure the safe manufacture, distribution, sale, and application of Stonhard products worldwide.

This position partners closely with Research & Development, Technical Services, Manufacturing, EH&S, Marketing, Procurement, Sales, and affiliated business units to maintain compliance with applicable chemical, transportation, environmental, and product stewardship regulations.

The Regulatory Affairs Manager serves as the company's primary resource for chemical compliance, hazard communication, Safety Data Sheet authoring and management, regulatory reporting, product stewardship, and customer compliance programs.

Scope of Position

This position is responsible for Stonhard's chemical regulatory compliance, product stewardship, SDS authoring and hazard classification, transportation compliance, environmental reporting programs, contractor qualification systems, customer compliance requirements, and specialized regulatory programs supporting continued business operations.

The role supports multiple Stonhard business units and affiliated RPM companies while ensuring compliance with evolving global regulatory requirements.

Essential Functions

1. Global Chemical Regulatory Compliance

  • Manage compliance with U.S. TSCA, EU REACH, UK REACH, EU CLP, GHS, WHMIS, and other applicable global chemical regulations.
  • Conduct chemical reviews and raw material evaluations with R&D and Technical Services personnel.
  • Evaluate new raw materials, formulations, and product changes for regulatory impact.
  • Coordinate with RPM affiliates and other business units regarding import/export compliance and product stewardship initiatives.
  • Monitor developing chemical regulations and assess business impacts.

2. Safety Data Sheet (SDS) Management

  • Create, author, maintain, publish, and manage the lifecycle of Safety Data Sheets (SDSs) across multiple brands and global regions.
  • Ensure compliance with OSHA Hazard Communication, GHS, WHMIS, EU CLP, and country-specific SDS requirements.
  • Classify products and determine appropriate hazard classifications, precautionary statements, regulatory disclosures, and labeling elements for SDS development and maintenance.
  • Maintain SDS availability through Product Vision, SharePoint platforms, customer portals, quoting systems, and company websites.
  • Coordinate SDS updates, revisions, translations, and multilingual document maintenance activities.
  • Provide SDSs and product safety information to customers, sales personnel, regulatory agencies, and affiliated business units.

3. Product Stewardship and Formula Review

  • Review formulas and raw materials for regulatory compliance and product stewardship impacts.
  • Perform CAS number validation, trade secret reviews, supplier consistency assessments, and raw material approvals.
  • Support chemical inventory management and product regulatory classifications.
  • Respond to customer and supplier requests involving product regulatory compliance and chemical disclosures.

4. Transportation Compliance

  • Maintain transportation classifications and shipping data within ERP and regulatory systems.
  • Ensure compliance with U.S. DOT, IMDG, IATA, and other applicable transportation regulations.
  • Review shipping classifications, packaging requirements, labels, and transportation documentation.
  • Support domestic and international transportation compliance activities.

5. Regulatory Reporting and Environmental Compliance

  • Manage federal, state, and international chemical and environmental reporting requirements.
  • Lead Extended Producer Responsibility (EPR) packaging compliance programs and producer reporting requirements.
  • Coordinate reporting through Circular Action Alliance and other regulatory stewardship organizations.
  • Complete TSCA 12(b), packaging, PFAS, and other applicable reporting obligations.
  • Monitor emerging environmental regulations and assess impacts on company operations and products.

6. Poison Centre and Specialized Regulatory Programs

  • Manage European Poison Centre Notification (PCN) submissions for Stonhard products.
  • Create and maintain Unique Formula Identifier (UFI) information and required ECHA submissions for applicable Stonhard products.
  • Coordinate compliance activities with internal stakeholders and regulatory authorities.
  • Monitor regulatory developments affecting poison centre notification requirements and product stewardship obligations.

7. International Regulatory Support

  • Provide regulatory support to Stonhard Canada, Stonhard Mexico, FPT Infrastructure, and affiliated RPM companies.
  • Serve as a regulatory resource for international business units and distributors.
  • Develop and maintain regulatory and product stewardship documentation supporting international business operations.

8. Product Literature and Marketing Review

  • Review and approve Product Data Sheets (PDS), technical literature, labels, directions for use, and marketing materials for regulatory accuracy and compliance.
  • Ensure consistency between product claims, product classifications, product stewardship requirements, and applicable regulations.
  • Support development and approval of customer-facing product stewardship and compliance communications.

9. EH&S Support

  • Provide technical regulatory support to Environmental, Health & Safety initiatives.
  • Participate in Management of Change (MOC) reviews and compliance evaluations.
  • Support industrial hygiene, respiratory protection, fit testing, and safety improvement initiatives.
  • Assist with safety stand-downs, training materials, and compliance communications.

10. Regulatory Inspections and Agency Interaction

  • Support regulatory inspections, audits, and compliance inquiries as required.
  • Serve as a backup company representative during regulatory inspections and agency interactions in the absence of the EH&S Manager.
  • Interface with federal, state, provincial, and international regulatory agencies regarding product compliance and regulatory matters.
  • Coordinate responses to regulatory requests and compliance-related inquiries.

Minimum Requirements

  • Bachelor's Degree in Environmental Sciences, Chemistry, Regulatory Affairs, Occupational Health & Safety, Safety Sciences, or a related discipline.
  • Five or more years of experience in Regulatory Affairs, Product Stew, Environmental Compliance, EH&S, or a related field.
  • Strong knowledge of global chemical regulations, hazard communication requirements, transportation regulations, and product stewardship principles.
  • Experience with SDS authoring systems, ERP systems, and regulatory databases.
  • Excellent verbal, written, organizational, and interpersonal skills.
  • Ability to manage multiple projects, regulatory programs, and business priorities simultaneously.

Physical Requirements

  • While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel and talk or hear.
  • The employee is frequently required to stand, walk and reach with hands and arms.
  • The employee is occasionally required to sit; stoop, kneel, crouch, or crawl.
  • The employee must regularly lift and /or move up to 10 pounds; frequently lift and/or move up to 20 pounds; and occasionally lift and/or move up to 50 pounds.
  • Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • This position requires occasional wearing of safety glasses, gloves, steel-toed boots with additional specific PPE depending on the chemicals or materials handled, which could include respirators, hearing protection, or specialized gloves for hazardous substances while on the worksite.

Benefits and Compensation

The pay range for applicants in this position generally ranges between $90,000 and $120,000. The range is an estimate based on potential employee qualification operations, needs, and other considerations permitted by law.

In addition to career advancement and growth, continuous training, and mentoring opportunities, Stonhard offers an excellent comprehensive health plan and financial benefits program including but not limited to, paid holidays, paid time off, 401(k) with company match, Company Pension Plan and Stock Purchase Plans.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.