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.
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.
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, 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.
Associate Director, Regulatory Affairs - CMC PTC TherapeuticsAssociate Director, Regulatory Affairs - CMCWarren, Michigan$169,100–$212,800 / yearLeads 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.
Product Regulatory Affairs Engineer III Daimler Truck North AmericaProduct Regulatory Affairs Engineer IIIDetroit, MichiganCreate and optimize processes, checklists, and work instructions with cross-functional teams in engineering and operations to ensure products remain compliant throughout the change cycle; Identify any gaps in process execution or adherence and drive appropriate corrective actions. Create documentation for notification to agencies of any product change that impacts emissions or modifies/amends the certification application documents for all engine families, as required by regulation; Coordinate responses to regulatory authorities regarding any questions or concerns they may have on the change notice.
Manager, Government Affairs Ezee FiberManager, Government AffairsTroy, MichiganFull timeGuided by our core values of Integrity, Compassion, Accountability, and Collaboration , we empower our employees to do the right thing, support one another, take ownership of their work, and work together to deliver exceptional experiences for our customers and the communities we serve. 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.
Staff Medical & Scientific Affairs Liaison - Cardiometabolic Danaher CorpStaff Medical & Scientific Affairs Liaison - CardiometabolicDetroit, MIRemote$130,000–$170,000 / yearPrimary responsibilities include developing and cultivating strong relationships with key opinion leaders (KOLs) and healthcare professionals, identifying unmet needs/scientific gaps in medical research and clinical practice paradigms, and cross functional collaboration with internal partners to deliver field and medical insights. Communicate & streamline complex scientific information effectively to the broader MSL organization, ensuring a clear understanding of the benefits and clinical utility of our cardiometabolic diagnostics e.g., provide clinical support during voice of customers sessions.
Senior Manager, Product Management - Delivery & Operations Product Lead - Medical Affairs Domain Regeneron PharmaceuticalsSenior Manager, Product Management - Delivery & Operations Product Lead - Medical Affairs DomainWarren, MichiganTechnical Experience and ability to Partner with data science and integration teams to build, validate, and operationalize AI solutions using APIs, middleware, and AI/ML platforms (e.g., NLP, large language models, predictive analytics). Configure and optimize Veeva CRM components, including but not limited to: Medical Inquiry, Call Reporting, Key Medical Insights, Events, Approved email, Consent Management, Page layout, Profiles, Permission sets and Sharing Rule.
Regional Government Affairs Director - Central and Southeast ModivCare Inc.Regional Government Affairs Director - Central and SoutheastSouthfield, MI$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
VP, Chief Medical Affairs (Henry Ford Health) Shirley Ryan Ability LabVP, Chief Medical Affairs (Henry Ford Health)Detroit, MIThe VP and CMA will lead on all aspects of physician recruitment, oversight of physician performance and medical practice quality indicators, and operational oversight for all physical medicine and rehabilitation (PM&R) physicians and Advanced Practice Providers (APP) practicing across the HFH system of care, serving as the highest-ranking leader representing Shirley Ryan AbilityLab (SRAlab) at HFH. The CMA will oversee physician and APP coverage, ensure seamless coordination of care across HFH sites, and advocate for academic, scientific, and professional excellence in rehabilitation services, including the development of a HFH Department of PM&R.
Public Affairs Manager, Regional Data Centers Google LLCPublic Affairs Manager, Regional Data CentersDetroit, MIFrom software to hardware our teams are shaping the future of world-leading hyperscale computing, with key teams working on the development of our TPUs, Vertex AI for Google Cloud, Google Global Networking, Data Center operations, systems research, and much more. We"re the driving force behind Google"s groundbreaking innovations, empowering the development of our cutting-edge AI models, delivering unparalleled computing power to global services, and providing the essential platforms that enable developers to build the future.
VP, Chief Medical Affairs (Henry Ford Health) Shirley Ryan AbilityLabVP, Chief Medical Affairs (Henry Ford Health)Detroit, MichiganThe VP and CMA will lead on all aspects of physician recruitment, oversight of physician performance and medical practice quality indicators, and operational oversight for all physical medicine and rehabilitation (PM&R) physicians and Advanced Practice Providers (APP) practicing across the HFH system of care, serving as the highest-ranking leader representing Shirley Ryan AbilityLab (SRAlab) at HFH. The CMA will oversee physician and APP coverage, ensure seamless coordination of care across HFH sites, and advocate for academic, scientific, and professional excellence in rehabilitation services, including the development of a HFH Department of PM&R.
Global Medical Affairs Operations Manager MedelaGlobal Medical Affairs Operations ManagerDetroit, MIThis role is a critical connector across Medical Affairs, Clinical, Sales, Marketing, and external healthcare partners to ensure successful delivery of scientific and educational programs that improve outcomes in maternity and neonatal care. This person will lead the execution of global Medical Affairs programs, educational initiatives, and real-world evidence activities supporting healthcare professionals and customers worldwide.