- Merck & Co. (Rahway, NJ)
- … Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory Affairs & Clinical ... and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head… more
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product ... Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they...point of contact for interactions with FDA and other Global health authoritiesAssist/ Lead communications with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...years of experience managing direct reports. Competencies: Ability to lead in a highly collaborative global environment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory...tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal… more
- Merck & Co. (Durham, NC)
- …and effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict ... defined business requirements through exceptional project management. The incumbent will lead cross-functional teams for projects that may include establishing new… more
- Merck & Co. (Rahway, NJ)
- … regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.Proven ... and mentor others to grow their technical rigor to lead and/or contribute to regulatory submissions and...technical rigor to lead and/or contribute to regulatory submissions and audits.Innovation and Continuous Improvement:Stay abreast of… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... , cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs, or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas ... global projects with high impact with ability to lead and project-manage cross-functionally and globally with business stakeholders is highly-preferredMust… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good distribution ... design and execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will … more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
- Merck & Co. (North Wales, PA)
- …Analytics, Medical Affairs, Policy, Payer Marketing, Finance, Manufacturing, L&D, Global Communications, Regulatory , Legal/Compliance Manage agency relationships ... Marketing Owner - HCP for HIV. As a key leader within our rapidly growing Business Unit, you will...be based in the Upper Gwynedd, PA office.You will lead and mentor a high-performing CAT, comprised of several… more
- Merck & Co. (Boston, MA)
- …principles.Prior experience in drafting regulatory documents and interactions with global regulatory agencies requiredSelf-driven leader willing to ... Rheumatology and Dermatology we are seeking an experienced experimental medicine leader in our newly created Precision Medicine and Diagnostics function. Reporting… more
- Merck & Co. (Rahway, NJ)
- …leading and growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and industry standards.Strong ... and represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence Serve as… more
- Merck & Co. (Millsboro, DE)
- …aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly...vaccine production at scale. If you are a people-first leader with deep technical experience in aseptic filling and… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... and CROs. Lead internal audits and represent the affiliate in global QA forums. Maintain SOPs, Crisis Management documentation, and Risk Management Plans.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders Job Summary: The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all ... advertising and promotion team, ensuring alignment with corporate goals and priorities. Lead , mentor, and develop a team of regulatory ad/promo… more
- Merck & Co. (Rahway, NJ)
- …Continuity Planning (BCP), including identification & prioritization of mitigation strategies. Lead Global Filing and Launch (GFLS) strategy development to ... manufacturing operations, technology, quality, and supply chain.- Proven ability to lead global , cross-functional teams through complex strategy/ project… more
