- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate … more
- Eisai, Inc (Cincinnati, OH)
- …If this is your profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership, direction and management of MSLs ... in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical … more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects; and Assist the Executive Director /AVP in ensuring that appropriate corporate personnel...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… 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 ... product release, aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …programs + And more **Work Location:** Atlanta, GA **Description** The Corporate Director of Regulatory Affairs is an operational leader responsible for ... activities and readiness across the health system. The Corporate Director of Regulatory Affairs ensures that all facilities consistently meet federal,… more
- Penn Medicine (Philadelphia, PA)
- …Street, Philadelphia, PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible… more
- Chemours (Providence, RI)
- …living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! This position ... Affairs Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States Environmental Protection Agency… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …we can continue making a positive impact in the cancer field. The Associate Director , Regulatory Affairs , Advertising and Promotion is responsible for ... Associate Director will report to a Senior Director in Regulatory Affairs , Advertising...labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities...multiple audiences This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our ... the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and... regulatory policies, processes, and SOPs. + Evaluate regulatory risks of corporate policies. + Provide… more
- Medtronic (Lafayette, CO)
- …to innovation in a more connected, compassionate world. **A Day in the Life** As the Director of Regulatory Affairs , you are a critical leader and the ... development to build a high-performing and scalable organization. Mentor and coach senior regulatory affairs managers to enhance their skills and foster future… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- Organon & Co. (Jersey City, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and ... **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting...entire life cycle of the drug. + Represent Global Regulatory Affairs within our company's internal committees… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , Corporate Affairs , Global Media Relations** **What you will ... as a company spokesperson and media strategist on the global relations team. The Director , Corporate Affairs , Enterprise Media Relations will be responsible… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for… more
- GRAIL (Menlo Park, CA)
- …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 ... listings. + Serve as a key member of the Regulatory team, offering insights and solutions on corporate...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... strategically and operationally to development projects and marketed product regulatory issues to support corporate goals. +...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
