- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and congress activities + Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory , and Commercial ... meetings + Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. + Author, approve or support the writing of URSs (User… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility * Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- Honeywell (Hamilton, NJ)
- …Experience with digital transformation initiatives in pharma or biotech. + Familiarity with global regulatory frameworks (eg, FDA, EMA, ISO). + Exposure to ... value propositions tailored to life sciences personas. + Align messaging with regulatory , operational, and innovation drivers in manufacturing and quality. + Partner… more
- J&J Family of Companies (Titusville, NJ)
- …responsibility * Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... end user. Support tech transfer activities through process validation and regulatory approval. + Ownership for clean utility systems throughout project execution,… more
- J&J Family of Companies (Titusville, NJ)
- …responsibility. * Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- Oracle (Trenton, NJ)
- …and stakeholder communication for smooth and timely rollouts. + **Support Global Compliance & Certification:** Collaborate with legal, regulatory , and ... **operational alignment with international compliance frameworks and medical device regulatory requirements** as HDI scales its solutions globally. **Responsibilities**… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility * Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... & Safety. The CQV Lead will partner closely with global E&PS and Quality to ensure validation strategies are...and automation. * Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)… more
- Bristol Myers Squibb (Princeton, NJ)
- …experience in nearly all phases of research and drug development, including global regulatory submissions (IND/CTA through NDA/BLA/MAA/JNDA/ NDA China) and ... asset(s). They operate as a strategic partner to the Global Program Lead (GPL), to shape and deliver the...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more