of solutions that safeguard and improve human health. This position is part of the Regulatory Affairs and Quality Assurance group... opportunity to: Support a team responsible for worldwide submission activities, maintenance of approvals and global regulatory...
. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization... contractors supporting the work of regulatory affairs is a plus. Experience authoring and/or implementing processes...
America Regulatory Affairs team to execute the short and long term regulatory strategic direction for PC categories, leading... and global PC Regulatory Affairs team, Safety, Environmental & Regulatory Science (SERS), CTI, Packaging, etc., to assure...
. Regulatory Affairs Director - Inflammation and Rare Disease What you will do Let’s do this. Let’s change the world. Amgen... is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global...
and Experience: Must-Have: Minimum Requirements Requires a Baccalaureate degree Minimum of 4 years of regulatory affairs.... Regulatory Specialist will provide both pre-market and post-market regulatory support for Neuromodulation and Pelvic Health...
in regulatory affairs. Providing leadership in CMC team by directing analytical, DP part of CMC development for multiple product...Remote Job Pay Range: $45 - $49 Responsibilities: Develop global regulatory strategy for lifesaving therapeutic...
Responsibilities: The Sr. Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex... regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams. Responsible...
liaison to commercial, medical affairs, legal, etc. to assure our practices are compliant with current regulatory standards... and forecasting for function and Regulatory Affairs department. Manage vendors and contractors as applicable. Other responsibilities...
Responsibilities: You will be a part of the Regulatory Affairs and Quality Affairs and report to the Director..., Regulatory Affairs responsible for an RA team that supports new product development and ensures market access is maintained...
. Regulatory Affairs Specialist – Animal Tissue will report to the VP of Regulatory Affairs and have the following primary...Overview: Candidate will be responsible for regulatory activities related to Animal Tissue Responsibilities: The Sr...
Role Overview Responsible for all regulatory affairs activities required to support lead, manage, review, and submit... compliance. Primary Duties & Responsibilities Regulatory Affairs: o Lead and manage all regulatory affairs-related...
changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings... subject. A minimum of five years of experience in the Medical Products Industry in Regulatory Affairs. Able to assess...
About the Job The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities... outcome data. Manage and mentor junior members of the Regulatory Affairs Team. Represent Regulatory Affairs department...
. (Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field. Combination of education...Responsibilities: Prepare and submit regulatory documentation for domestic and international markets, ensuring...
portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling... The Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development...
and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs.... Establishes clear and consistent ways of working across the alliance with regard to work that impacts US regulatory affairs...
, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams...: A minimum of a bachelor's degree in a scientific, technical, or related discipline. A minimum of 8 years Regulatory Affairs experience in the...
SUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines... experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience. Exhibits excellent...
, submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA..., User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R...
, submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER..., FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance...