- Olympus Corporation of the Americas (Westborough, MA)
- …and connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning ... traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Olympus Corporation of the Americas (Westborough, MA)
- …responses to regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health...registration on for other international markets such as Japan, Middle East and Africa,… more
- Lundbeck (Deerfield, IL)
- …+ Global Regulatory Affairs Experience. + Exposure to international regulatory affairs , including participation in submissions to ex-US ... open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... Transparency Language:The annual base salary range for the Director, Global Regulatory Affairs , Growth Markets is from :$200,800-$263,600Under current… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... multiple regions (US, EU, and/or other international markets)Strong knowledge of global regulatory requirements and submission formats (eCTD)Proven experience… more
- GRAIL (Helena, MT)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and governance of ... Regulatory Affairs department and involved in the day-to-day support of...knowledge of Food and Drug Administration (FDA) regulations and International Conference of Harmonisation (ICH) and Good Clinical Practice… more
- Parexel (Columbia, SC)
- …- Work on impactful global programs that directly support patient safety and regulatory compliance. - Collaborate with a diverse, international team across ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Lundbeck (Deerfield, IL)
- …sign-off authorization. + Ensures all activities are following ICH, and other international regulatory guidelines and relevant GCPs and SOPs. + Participates ... and KOL relationships and collaborating with other functions (eg, Value Evidence, Regulatory , Clinical Development, Brand Teams, Global Medical Affairs etc.) in… more
- The Clorox Company (Washington, DC)
- …company's strategic business objectives. Additionally, refine and help guide the External Affairs approach in international markets in which the Company ... or related field. + At least 8 years' experience in government affairs and legislative and regulatory processes at the federal and/or state level. Must also have… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... **SUMMARY:** The Senior Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the Vice President, Rare Neurology,… more
- Lundbeck (Deerfield, IL)
- Director Medical Affairs , Rare Epilepsies Evidence Generation Requisition ID: 7165 Location: Deerfield, IL, US Do you want to join a team where the mission is ... States** **SUMMARY:** The Director of Rare Epilepsies Evidence Generation within US Medical Affairs will report to the Senior Director and Head of Rare Epilepsies,… more
- Endo International (St. Louis, MO)
- …of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of ... + Minimum 5 years managerial experience in a pharmaceutial quality/ regulatory affairs environment. _Preferred Skills/Qualifications:_ + Previous experience… more
- Genmab (NJ)
- …to be a part of an exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and collaborative setting.The Director, HEOL ... Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the US Medical Affairs strategy in support of the US business… more
- Endo International (St. Louis, MO)
- …Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director, Quality and Regulatory Affairs . Manages group of exempt direct reports. Develops strategic ... basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. + Knowledge of US and International … more
- FM (Johnston, RI)
- …of Corporate Affairs matters including: - Contract review - Legal, regulatory , compliance, risk, and corporate governance matters - Corporate regulatory ... in support of the provision of technical advice and recommendations to Corporate Affairs Counsel, the Manager, Corporate Affairs , and internal business units, as… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and cross-functionally to develop strategy relating to IME and External… more
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