- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Compassionate Use or Managed Access Programs.Collaborate with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring ... in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and… more
- Merck & Co. (Rahway, NJ)
- …and execution globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety ), Research and Development (R&D), ... This individual will be a senior member of the Regulatory Affairs CMC organization and will also...mitigation, and overall plan to the Regulatory Affairs , R&D, Manufacturing and GHH management teams, product… more
- Merck & Co. (Durham, NC)
- …and effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict ... materials or managing a portfolio of complex process changes with regulatory impact Responsibilities Business Case Development Understanding the requirements of a… more
- Eisai, Inc (Nutley, NJ)
- …scientific literature for potential adverse event reports; report findings to Product Safety within established timeframes. Research and conduct detailed ... visible member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to:Utilize clinical and… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory requirements and commercial goals to guide product development strategies. ... product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety , Regulatory Affairs , Epidemiology) to ensure benefit-risk ... the signal workflow to ensure compliance with procedural documents.When required, assist the product safety teams in the entering of key signal information into… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... regulatory /in-house requirements (may include but not limited to safety , housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the… more
- Henkel (Rocky Hill, CT)
- Product Safety & Regulatory Affairs Intern - Summer 2026 **_About_** **_this_** **_Position_** At Henkel, you'll be part of an organization that's ... compliance documents, including scanning and archiving materials + Support product safety and regulatory compliance by gathering and analyzing health… more
- Henkel (Rocky Hill, CT)
- Product Safety and Regulatory Affairs Intern - Summer 2026 **_About_** **_this_** **_Position_** At Henkel, you'll be part of an organization that's ... make an impact at Henkel.** **What you'll do** As a Product Safety and Regulatory Affairs Intern, you will: + Gain hands-on experience with regulatory… more
- Henkel (Westlake, OH)
- Product Safety and Regulatory Affairs Specialist **_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the ... chemistries and processes Leads regional and global product safety and regulatory affairs projects to simplify, harmonize and streamline processes… more
- Eastman Kodak Company (Rochester, NY)
- …Required Skills/Experience: * Experience in Environment, Health, and Safety (EHS) product regulatory affairs and competency with respect to global ... Product Stewardship Specialist to join our WW Health, Safety and Environment team onsite in Rochester, NY. As...with good chemistry knowledge Minimum 1-3 years of relevant Product Stewardship or chemical and/or materials regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- …development requirements including preparation of documentation, as appropriate **Description** The Regulatory Affairs Product Strategy Fellowship is ... advocate to achieve common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory… more
- Abbott (Alameda, CA)
- …+ Oversee system to ensure that product safety issues and product -associated events are reported to regulatory agencies. + Provide regulatory input ... metrics/information. **What You'll Work On** + Develop global regulatory strategies for product development and planning...with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.… more
- Haleon (Warren, NJ)
- …as part of our worthwhile contribution to public health and welfare. Regulatory Affairs plays a critical role in managing product lifecycle, starting from a ... multiple departments to achieve a product fit for the public. Regulatory Affairs continuously needs to monitor for external changes being introduced in our… more
- J&J Family of Companies (Santa Clara, CA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... States of America **Job Description:** Johnson & Johnson is hiring for a **Manager, Regulatory Affairs - Shockwave Medica** l to join our team. The position… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(CCDS) for assigned products. + Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS ... Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a… more
- Terumo Aortic (Sunrise, FL)
- Regulatory Affairs Associate II Date: Sep 19, 2025 Req ID: 5116 Location: sunrise, FL, US Company: Department: At Terumo Aortic, our mission is to transform the ... the lives of patients in over 100 countries worldwide. www.terumoaortic.com JOB TITLE Regulatory Affairs Associate II DEPARTMENT Regulatory Affairs … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow ... reflect Boehringer Ingelheim's high regard for our employees. The Regulatory Affairs (RA) Fellowship within the Chemistry,...- review the reports for potential CMC impact to safety of the product . + NDA Field… more
- ThermoFisher Scientific (Grand Island, NY)
- …Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager, Regulatory Affairs - Drug Support Strategy is a new role responsible ... collaborate with and lead all aspects of professionals in regulatory affairs to develop detailed drug support...communicate impact of relevant global regulations, guidelines and evolving regulatory trends. + Assessment of product changes… more
