NewSenior Medical Science Liaison Rare Epilepsies- North Central LundbeckSenior Medical Science Liaison Rare Epilepsies- North CentralDetroit, MI$180,000–$220,000 / yearStrategic Scientific Engagement & Insight Generation: Establishes and sustains deep, longitudinal scientific partnerships with Key Opinion Leaders (KOLs), Centers of Excellence, and investigators working in rare epilepsies. This role serves as a strategic pre-launch scientific partner to external experts and internal stakeholders, generating high-quality, actionable insights that inform evidence strategy, disease education, portfolio decision-making, and launch readiness.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsManager, Regulatory Affairs, Advertising & PromotionWarren, MI$128,600–$210,000 / yearHelp 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. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionWarren, Michigan$150,500–$245,500 / yearHelp 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. 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.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron PharmaceuticalsAssociate Manager, Regulatory Affairs Strategy - OncologyWarren, MichiganCoordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure. The Associate 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 including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Manager, Regulatory Affairs Strategy - Oncology Regeneron PharmaceuticalsManager, Regulatory Affairs Strategy - OncologyWarren, MichiganThe 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 including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.
Regulatory Affairs Specialist – SDS & Chemical Compliance (TSCA/DSL) Manpower EngineeringRegulatory Affairs Specialist – SDS & Chemical Compliance (TSCA/DSL)Madison Heights, MITemporaryp> 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.
Principal Regulatory Affairs Specialist, (Hybrid) StrykerPrincipal Regulatory Affairs Specialist, (Hybrid)Portage, MichiganIn this highly visible role, you will partner closely with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks, support due diligence activities related to acquisitions and partnerships, and help drive informed business decisions. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Senior Specialist, Regulatory Affairs Stryker CorpSenior Specialist, Regulatory AffairsPortage, MIRemote$83,300–$138,800 / yearHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Join a team that supports regulatory initiatives across the product lifecycle, with a focus on sustaining and environmental regulatory activities to help ensure products remain compliant with applicable global regulatory requirements.
Director, Regulatory Affairs - CMC PTC TherapeuticsDirector, Regulatory Affairs - CMCWarren, Michigan$193,500–$243,600 / yearWorks with GRA functions 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. This position works cross-functionally with Regulatory Affairs, Technical Operations, Quality, and program teams to facilitate the completion of regulatory submissions through regulatory approvals in accordance with company goals and timelines.
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines Perrigo Co PlcProfessional Regulatory Affairs - Lifecycle Management - Non-MedicinesAllegan, MIWe are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigos non medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities.
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines Perrigo Company CorporateProfessional Regulatory Affairs - Lifecycle Management - Non-MedicinesAllegan, MIWe are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigo's non medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities.
Summer 2027 Internship - RA/QA - Regulatory Affairs - Michigan Stryker CorpSummer 2027 Internship - RA/QA - Regulatory Affairs - MichiganPortage, MIHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. You will contribute to projects that ensure our products meet regulatory requirements and reach patients safely and effectively: Perform regulatory intelligence activities to monitor changes in global regulations and support strategy updates.
NewSummer 2027 Internship - Ra/Qa - Regulatory Affairs - Michigan Stryker CorporationSummer 2027 Internship - Ra/Qa - Regulatory Affairs - MichiganPortage, MIHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. You will contribute to projects that ensure our products meet regulatory requirements and reach patients safely and effectively: Perform regulatory intelligence activities to monitor changes in global regulations and support strategy updates.
NewDirector, Export/Import Regulatory Affairs (ITAR/EAR) FAAC Simulation TechnologyDirector, Export/Import Regulatory Affairs (ITAR/EAR)Ann Arbor, MIAs Ignium’s senior trade authority, you will architect the systems, policies, and behaviors that keep our cross-border business secure and compliant across our subsidiaries worldwide. Ensure adherence to U.S. Customs regulations; oversee import/export documentation and customs broker performance.
Sr. Staff Regulatory Affairs Specialist VB SpineSr. Staff Regulatory Affairs SpecialistAllendale, MichiganAt VB Spine, join a high-performing Regulatory Affairs team where you’ll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies. Demonstrated knowledge of regulatory pathways, risk-benefit analysis, submissions, registration, compliance, post-market surveillance, and distribution.
Director/Senior Director, Regulatory Affairs Tenpoint TherapeuticsDirector/Senior Director, Regulatory AffairsWarren, MichiganRepresent Regulatory Affairs in strategic discussions, influencing key decisions for clinical development and commercialization as well as with licensing partners in regard to regulatory activities. That’s why we offer a competitive benefit package to attract the very best talent to our team and to take care of our employees and their families.Below is a snapshot of our U.S. benefits package for full-time employees.
Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements Wacker Chemie AGSenior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary SupplementsAnn Arbor, MIEvaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care. Adobe will use this information on behalf of the owner of the Website to evaluate how users use the Website, to generate reports about website activity, and to provide the website owner with additional services relating to the usage of the Website and Internet usage.
Regulatory Affairs Specialist Delta Dental Plan of MichiganRegulatory Affairs SpecialistOkemos, MichiganPosition requires knowledge of legal research tools, such as NILS and Westlaw; knowledge of National Association of Insurance Commissioners (NAIC) rules and regulations and System for Electronic Rate and Form Filing (SERFF), as well as experience dealing with departments of insurance, preferred; excellent interpersonal skills; effective verbal and written communication skills; attention to detail; ability to multitask, work under deadlines and change priorities on short notice. At Delta Dental of Michigan, Ohio, and Indiana we work to improve oral health through benefit plans, advocacy and community support, and we amplify this mission by investing in initiatives that build healthy, smart, vibrant communities.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMI$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron PharmaceuticalsDirector, Regulatory Affairs Strategy - Genetics MedicineWarren, MI$205,000–$341,600 / yearThe 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. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.