This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...
Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Perform other regulatory tasks as assigned. Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. ...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
You will report to the Senior Director of Regulatory Affairs CMC and be part of the Regulatory Affairs CMC team consisting of 8 experienced and dedicated colleagues. Director/Associate Director, Global Regulatory Affairs - CMC. The project portfolio at Genmab is evolving, and we are therefore lookin...
Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketi...
Join our dynamic and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize your knowledge and experience to build a stronger Regulatory Operations team by providing guidance, as well as regulatory system and process support for th...
This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory proce...
Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Ideal candidates should have experience within QA and/or Regulatory Affairs department in a pharmaceutical or R&D company. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsi...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Ability to interpret Regulat...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Implements regulatory strategies and solutions to assure all adverti...
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. In this role you’ll be working with cross-functional teams to assist with the coordination and completion of international regulatory documents. This role will ...
Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. ...
On-Board Scientific is hiring a Regulatory Affairs Assistant!. The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and ...
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
The Princeton Plasma Physics Laboratory seeks to fill an Equitable Energy Transition Program Manager position at PPPL in the Science Education Department. All PPPL employees are required to disclose any participation in a foreign government talent recruitment program and may be required to withdraw ...
Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
Effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencie...
Cherry Hill Programs brings the magic to every experience by capturing moments that last a lifetime. In partnership with retail locations, tourist attractions, and destinations across North America, Cherry Hill Programs contributes millions of holiday and souvenir experiences for children and famili...
Regulatory Compliance Specialist (14450840). Senior Regulatory Compliance Specialist. Senior Regulatory Compliance Specialist. Supplier Quality, Regulatory Compliance, DEA, and QMS. ...