- Parexel (Trenton, NJ)
- …and approved programs, helping to shape the future of life-saving therapies. As a **CMC Regulatory Affairs Senior Associate ** , you will play a ... (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. + Proven experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs , Medical Analytics will be ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising...compliant manner. As part of the Regulatory Affairs team, you will report to the Senior… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- United Therapeutics (Trenton, NJ)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- J&J Family of Companies (Titusville, NJ)
- …of America, Titusville, New Jersey, United States of America **Job Description:** ** Senior Manager/ Associate Director, Regulatory Medical Writing X-TA** At ... at https://www.jnj.com/innovative-medicine We are searching for the best talent for a ** Senior Manager** **/ Associate Director** , ** Regulatory Medical… more
- Bristol Myers Squibb (Princeton, NJ)
- …Associate Director Regulatory Policy brings an expertise in regulatory affairs and related policy. The Associate Director, Regulatory Policy is ... Read more: careers.bms.com/working-with-us . **Job Purpose:** This position is focused on regulatory policy to ensure appropriate and effective regulatory policy… more
- System One (Bridgewater, NJ)
- …the Associate Director, Quality or Vice President, Quality. The Quality Assurance Senior Associate plays a key role in maintaining and enhancing product ... Title: Regulatory /QA Sr. Associate Type: Direct Hire...cross-functionally with teams including Operations, Sales, Medical & Scientific Affairs , and Innovation. We are seeking a proactive, solution-oriented… more
- Bristol Myers Squibb (Princeton, NJ)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. + Ability to broadly… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... ** Associate Director, Small Molecule Analytical Development** + Lead...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- Bristol Myers Squibb (Princeton, NJ)
- …integration points across US functional and commercialization areas to ensure alignment. The Associate Director will report to the Senior Director, US Medical ... work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director, US Medical Neuropsychiatry position works in the US Medical… more
- J&J Family of Companies (Titusville, NJ)
- …nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs , Commercial and Quality functional groups. + Demonstrated ... Essential Job Duties and Responsibilities The overall purpose of the Commercial Quality, Senior Manager/QA Associate Director for the US LOC is to ensure… more
- J&J Family of Companies (Raritan, NJ)
- …for the best talent for a Sr.** **Administrative Assistant to support our Global Regulatory Affairs team in Raritan, NJ.** _Per our J&J Flex Policy, the ... card balances, including meeting card accounts, are reconciled monthly for senior leaders and during complex international travel. + Organizational Management: Own… more
