for diversity, working mothers, female executives, and scientists The Opportunity We are seeking a Regulatory Affairs Manager... Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed...
Responsibilities: The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory... with at least 7 years of experience within International Regulatory Affairs. At least 5 years of experience in Regulatory Affairs...
Details: Title: Regulatory Affairs Manager Schedule: 8:30 am - 5:00 pm, M-F, with some flexibility. *This position is ONSITE... in Regulatory Affairs, with preferably 2+ years leadership/people management. Location: Gibbstown, NJ (08027) Essential...
, which provides support to Liberty’s regulated utilities in the East region. This position is responsible for all regulatory affairs... and rates related functions in multiple jurisdictions. The Manager will support the Regional Director, on other regulatory...
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post... in FDA regulated industry. At least 3 years of experience in CMC regulatory affairs. Experience with biologics...
. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization.... You will represent RA Ad/Promo in Regulatory Project Teams and labeling meetings; providing strategic regulatory guidance and seeking...
affairs and marketing. 2. Advisory Responsibilities Participates in global teams and provides regulatory strategy... appropriateness. Works collaboratively with cross-functional team to resolve project issues. Has recognized regulatory expertise...
Standard Operating Procedures and internal guidance documents for related activities and provide training to Regulatory Affairs... as needed in the activities of the Global Regulatory Affairs group. Provide input to support trial designs within Chiesi to ensure...
affairs and marketing. 2. Advisory Responsibilities Participates in global teams and provides regulatory strategy... appropriateness. Works collaboratively with cross-functional team to resolve project issues. Has recognized regulatory expertise...
in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. 5-7 years of experience in regulatory affairs..., or other pharmaceutical modalities is preferred. Regulatory Affairs Certification (RAC) is a plus....
Responsibilities: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA... candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission...
communication channels, enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs... in a relevant field, such as life sciences, regulatory affairs, or a related discipline. Regulatory Certification (such as RAC...
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post... in FDA regulated industry. At least 3 years of experience in CMC regulatory affairs. Experience with biologics...
relationships with regulatory commissions & authorities. Develops programs and processes to manage complaint cases brought... to regulatory authorities and develops process improvements to avoid future complaints. Interacts with internal & external parties...
." Who we are looking for Purpose Perform and oversee strategic and operational aspects of Chiesi regulatory submissions... and oversee the effective and appropriate management of Chiesi regulatory documentation. Main Responsibilities Ensure...
. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up... to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects...
design, bring agility to manufacturing and supply chains, and improve patient care. The Sr. Regulatory Affairs Materials... Engineer will ensure compliance with regulatory standards and oversee projects related to regulatory affairs. This role...
Job Title: Regulatory Affairs Specialist Reports To: VP Quality & Regulatory Affairs Position Status: Exempt..., a Regulatory Affairs Specialist V is responsible for: * Preparing comprehensive regulatory strategies for complex new devices...
Title: Director, Clinical Regulatory Affairs Location: Brisbane About Us: Vera Therapeutics (Nasdaq: VERA... designation applications, NDAs/BLAs, and other regulatory submissions as applicable. Acts as regulatory representative on project...
regulatory filings, registrations and compliance. The Regulatory Affairs Specialist I reports to the Manager of Regulatory... and project management skills desirable 3+ years’ experience in Regulatory Affairs, preferably in a medical device company...