24 Results for

Regulatory Manager Jobs in Warren, MI

Jobs

Madison Heights, MI11 days ago

$26–$26 Per Hour

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Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by the company are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.).

Provide timely assessments of developmental materials, including chemical materials and formulations, in order to ensure their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.

Warren, Michigan23 days ago

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Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Warren, MI28 days ago

$150,500–$245,500 Per Year

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Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

Fraser, MI30+ days ago

Remote

The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.

New!

Warren, Michigan6 days ago

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

The Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert.

Warren, MI30+ days ago

$205,000–$341,600 Per Year

Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

New!

Warren, Michigan5 days ago

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Provides strategic oversight and leadership across therapeutic area(s), directing team members responsible for project managing regulatory milestones such as pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports; accountable for functional quality and consistency across the portfolio.
Serves as the senior escalation point and strategic advisor for team members and cross-functional groups, resolving complex issues related to timelines, submission documents, or regulatory matters impacting the timeliness or quality of submissions; establishes best practices and process improvements to enhance functional effectiveness.

New!

Detroit, MIToday

$71,000–$91,000 Per Year

This role also requires monitoring and investigating new complaints ofpossible emissions defects arising from warranty claim threshold exceedances, quality data, or internal data suggesting a possible defect. The Product Regulatory Affairs Engineer will ensure evaluations are managed cross-functionally, compliance evaluation processes are followed, and documentation is created and stored.

New!

Madison Heights, MI6 days ago

Temporary

p>ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

New!
Detroit, Michigan5 days ago
This schedule builds our #OneTeamBestTeam culture, provides an unparalleled customer experience, and creates innovative solutions through in-person collaboration.
At Daimler Truck North America, we recognize our world is changing faster than ever before. This role requires work in a cross functional environment with Aftermarket, Product Engineering, Product Integrity, and Legal teams.
Posting Information.

MI30+ days ago
p>With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science.

New!
Warren, Michigan6 days ago
$169,100–$212,800 Per Year
li>Leads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements.
Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.

Troy, Michigan29 days ago
The ideal candidate will possess strong communication and relationship-building skills, the ability to manage multiple priorities, and experience working with local governments, public agencies, or regulatory matters. Whether in the field, in the office, or behind the scenes, every team member plays a vital role in helping us provide fast, reliable, and straightforward connectivity solutions to the communities we serve.

Warren, Michigan30+ days ago
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The Senior Manager, Clinical Pharmacology conducts pharmacokinetic/toxicokinetic studies to support preclinical and clinical development of novel therapies and life cycle management.

Detroit, MI14 days ago
p>As part of working with clients you will help with several aspects of life sciences integrated planning including:
Integrated Planning Strategy: Design and implement IBP/S&OP frameworks tailored to life sciences environments, accounting for regulatory release cycles, CMO/CDMO network complexity, and the distinct planning dynamics of biopharma and med tech product portfolios.
Accenture is a leading solutions and services company that helps the world's leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, bringing together the talent of our approximately 786,000 people, our proprietary assets and platforms, and deep ecosystem relationships.

Detroit, MI30+ days ago
$144,200–$265,600 Per Year
The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.

MI15 days ago
$120,200–$140,000 Per Year
Lead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.

Royal Oak, MI30+ days ago
$50–$60 Per Hour
Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects. This position will lead or support a variety of large to medium size projects within Quality and Regulatory Affairs function.

MI30+ days ago
$105,000–$145,000 Per Year
p>Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. You will deliver pilot and pivotal clinical studies that support product registrations and provide expertise in companion animal medicine and study conduct to research and development phase projects.

Auburn Hills, MI7 days ago
$90,000–$137,000 Per Year
p>Job Location: San Diego, New Brighton, Seattle, Tampa, Auburn Hills, Groves, Portland, Wakefield, Los Angeles, San Francisco, Corpus Christi, La Porte, St. Louis, Cincinnati, Pasadena, Plymouth, Raleigh-Durham, Houston, Boston, Mammoth Lakes, Quincy, Schaumburg, Bakersfield, Erie, Grand Junction, Boston / Peabody, Clark, Shorewood, Billings, Las Vegas, Wild River, Woodbridge, Rancho Bernardo, Excelsior, Lafayette, Peabody, Belle Chase, Brecksville, Fremont, Grass Valley, Holland, Peabody/ New Brighton, Downey, Alpharetta.
Expand existing customer accounts and proactively acquire new business opportunities across the certification portfolio, including ISO 13485, MDSAP, EU MDR, IVDR, CE Marking, and related regulatory programs.

Auburn Hills, MI30+ days ago
p>Job Location: San Diego, New Brighton, Seattle, Tampa, Auburn Hills, Los Angeles, San Francisco, Corpus Christi, Groves, La Porte, Portland, Schaumburg, St. Louis, Wakefield, Bakersfield, Cincinnati, Erie, Grand Junction, Pasadena, Plymouth, Raleigh-Durham, Houston, Boston, Boston / Peabody, Clark, Shorewood, Mammoth Lakes, Quincy, Rancho Bernardo, Billings, Excelsior, Lafayette, Las Vegas, Peabody, Belle Chase, Brecksville, Fremont, Grass Valley, Holland, Peabody/ New Brighton, Wild River, Woodbridge, Downey, Alpharetta.
Expand existing customer accounts and proactively acquire new business opportunities across the certification portfolio, including ISO 13485, MDSAP, EU MDR, IVDR, CE Marking, and related regulatory programs.

Warren, Michigan19 days ago
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Has understanding of advanced PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods, Exposure-Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.
As a Senior Clinical Pharmacologist this individual is expected to plan, design, implement and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies working with Clinical Pharmacology, Quantitative Pharmacology, Pharmacometrics/Pharmacodynamics (PK/PD), Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development / Regulatory.

MI30+ days ago
Remote
$34.21–$47.48 Per Hour
p>Great Lakes and Great Times: Michigan boasts four Great Lakes, 11,000 inland lakes, 36,000 miles of rivers and streams, 20 million acres of forests, 100 state and national parks and recreation areas, 1,300 miles of bike trails, 6,500 miles of snowmobile trails, the second-most ski areas in the nation, 650 public golf courses, 600 campgrounds, and an international dark-sky park-just for starters.
View the job specification at: http://www.michigan.gov/documents/ElevatorInspector_12588_7.pdf.

Warren, Michigan23 days ago
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The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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Regulatory Manager Jobs in Warren, MI

Regulatory Affairs Specialist Joulé

Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals

Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals Inc

Senior Manager, Regulatory Affairs Getinge AB

Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals

Director, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals Inc

Associate Director, Regulatory Submission Project Management Regeneron Pharmaceuticals

Product Regulatory Affairs Engineer I Daimler Truck

Regulatory Affairs Specialist – SDS & Chemical Compliance (TSCA/DSL) Manpower Engineering

Product Regulatory Affairs Engineer I Daimler Truck North America

Regulatory Affairs Specialist I Getinge AB

Associate Director, Regulatory Affairs - CMC PTC Therapeutics

Manager, Government Affairs Ezee Fiber

Senior Manager, Clinical Pharmacology PTC Therapeutics

Life Sciences Supply Chain and Operations - Supply Chain Planning Manager Accenture Plc

Manager, Industry Solutions, Veeva Life Science Deloitte Touche Tohmatsu Ltd

Managed Services Sr. Consultant Deloitte Touche Tohmatsu Ltd

Corewell Histotechnician (Traveler) eTeam Inc.

Clinician, Companion Animal Clinical Development Zoetis Inc

Account Executive, MHS Certification TUV SUD AG

Senior Account Executive, MHS Certification TUV SUD AG

Senior Clinical Pharmacologist Regeneron Pharmaceuticals

Elevator Inspector E11 State of Michigan

Associate Director, Biostatistics - Genetic Medicine Regeneron Pharmaceuticals

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