- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.Health… more
- Randstad US (North Chicago, IL)
- associate regulatory affairs submission management. + north chicago , illinois + posted august 29, 2024 **job details** summary + $25 - $32.29 per hour + ... 32.29 per hour work hours: 9 to 5 education: Bachelors responsibilities: The Associate , Regulatory Affairs Submission Management, manages low to medium… more
- Haleon (Warren, NJ)
- …projects. **What will your individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as follows: + Work ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do...Associate with the opportunity to learn about FDA submission documentation, and a high-level overview of regulatory… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... Proposition: Join our dynamic and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC...in the development of relevant data to complete a regulatory submission . + Develop and communicate a… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive management with … more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- ICU Medical (Southington, CT)
- …will not be discriminated against on the basis of disability. **Title:** * Associate II, Regulatory Affairs * **Location:** *CT-Southington* **Requisition ... these changes for ease of regulatory agency review. . Represents Global Regulatory Affairs at research and development meetings and presents agreed upon … more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... Clinical Outcome Measurement preferred. + Experience in the CE Marking process, global regulatory strategy, and regulatory submission process. + Proven… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... and developing global filing strategies. + Co-lead marketing application submission teams for indications that are at regulatory... submission teams for indications that are at regulatory filing stage to develop content strategy for global… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. **PRINCIPAL DUTIES AND… more
- Stryker (Redmond, WA)
- …More information is available at www.stryker.com . We are currently seeking an **Senior** ** Regulatory Affairs Associate ** to join our **Medical Division** , ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with...+ Determine requirements (local, national, international) and options for regulatory submission , approval pathways, and compliance activities… more
- Stryker (Redmond, WA)
- …- finding ways to simplify, standardize and automate. We are currently seeking an ** Regulatory Affairs Associate ** to join our **Medical Division** , ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with...+ Determine requirements (local, national, international) and options for regulatory submission , approval pathways, and compliance activities… more
- Novo Nordisk (Princeton, NJ)
- …designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory ...positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs Strategy - Contractor Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL),...regulatory requirements. + Participate in the preparation and submission of regulatory documents related to QOL… more
- AbbVie (North Chicago, IL)
- …timely response to Health Authorities during application review. + Supports the regulatory submission and approval process. Broadly applies regulatory ... driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development… more
- Lilly (Indianapolis, IN)
- …knowledge. Become a patient advocate, as well as a medical expert. 6. Regulatory / submission responsibilities *Ensures that clinical data generated for ... solutions to support communities through philanthropy and volunteerism. **Purpose:** The Associate Vice President (AVP) - Cardiometabolic Health Global Medical … more
- Takeda Pharmaceuticals (Lexington, MA)
- … Regulatory Affairs promotion and advertising; experience managing major regulatory filing(s) (eg, launch advisory comment submission or responses to ... of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project… more
