- Sumitomo Pharma (Trenton, NJ)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part… more
- Organon & Co. (Jersey City, NJ)
- …to disseminate to senior leadership for further action. + Establish an international regulatory intelligence and policy network to ensure compliance with local ... or PharmD. with at least five years' experience in Pharmaceutical Industry or Academia. + Regulatory Policy...experience in Pharmaceutical Industry or Academia. + Regulatory Policy and Intelligence Professional with a proven track… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- Merck (Trenton, NJ)
- …Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, ... Pharmaceutical Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , Regulatory Reviews, … more
- System One (Florham Park, NJ)
- …Qualifications + Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. ... in accordance with established timelines and submission dates in compliance with local and global regulatory requirements...dates in compliance with local and global regulatory requirements for the different application types (eg, IND,… more
- Sanofi Group (Morristown, NJ)
- …record with a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical /medical device/biotech industry + Knowledge ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to… more
- Bristol Myers Squibb (Princeton, NJ)
- …Drug Promotion advisory submissions and sub part e submissions + Ensure full regulatory compliance of all promotions with approved labeling and /or FDA ... guidances + Ensure regulatory compliance with sub part e and... promotional review or related 5 to 8 years pharmaceutical experience (eg, Medical promotional review) + Experience providing… more
- Sanofi Group (Morristown, NJ)
- …Safety, and Medical Affairs, to ensure labeling content reflects scientific integrity, regulatory compliance , and supports safe and effective product use. We ... to maximize labeling value. + Assist in labeling submissions, regulatory queries, and updates to ensure compliance ...or medically related field. + Minimum 5+ years of pharmaceutical industry experience, with at least 3 years in… more
- System One (Florham Park, NJ)
- …sciences, pharmacy, bioscience; advanced degree preferred. + 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a ... Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10...IND applications and 1 NDA) + Knowledge of and Compliance with FDA, EMEA, PMDA guidances + Performance will… more
- Sanofi Group (Morristown, NJ)
- …project timelines for clinical trial initiation. + Supports operational and compliance activities for assigned deliverables, develops, executes regulatory ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...field) preferred. + At least 6 years of relevant pharmaceutical /biotechnology experience, including at least 4 years of relevant… more