The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Proficiency in all tasks outlined for Regulatory Associate. A Senior Associate is expected to have a strong understanding of ANDA requirements and demonstrate that knowledge th...
Translates and communicates regulatory requirements and strategies, as they affect regulatory submissions, to more junior regulatory team members and to internal and external functional business units. The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Aff...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labeling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, La...
Job Title: Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy (Associate Director). Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities. Develop global regulatory strategy for Oncology products in developmen...
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Proficiency in all tasks outlined for Regulatory Associate. A Senior Associate is expected to have a strong understanding of ANDA requirements and demonstrate that knowledge th...
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 marketing applications; HA responses & background p...
Chemical regulatory oversight and review. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. ...
Seeking a highly energetic and motivated individual to bring Regulatory expertise to an International Cosmetics Regulatory and Safety group supporting R&D to deliver fast-paced Beauty Care products to the market. Regulatory approval of cosmetic formula and artwork. Regulatory approval of raw materia...
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...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
Senior Regulatory Associate - Hybrid, NJ (2-3 days a week). You will be expected to prepare high-quality ANDA submissions (including amendments, supplements, and Annual Reports) with the support and oversight of the Senior Manager/Associate Director of Regulatory Affairs. Maintain and update senior ...
Chemical regulatory oversight and review. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. ...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
Regulatory Affairs Associate located in Clark, NJ. It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
It is not a lab-based role, but rather a corporate 'desk job' supporting regulatory registration for global product launches. ...
HM is looking for someone that has Canada and US artwork review experience, as well as notifying cosmetics in Canada - and a plus would be if they know how to assess the chemical regulatory aspects in Canada. Canada Chemical regulatory oversight and review. Position requires a Bachelor's degree in a...
Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsible for assisting the team with the maintenance quality and regulatory policies and procedures that ensure quality complian...
Translates and communicates regulatory requirements and strategies, as they affect regulatory submissions, to more junior regulatory team members and to internal and external functional business units. The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Aff...
Regulatory Affairs Labeling Associate Level – I is needed to support Client' business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational knowle...
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...
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 give you an opportunity to gain industry regulatory experience while helping deliver new therapies to patients and their families. Train and...
Description Kenvue is currently recruiting for: Senior Associate, Regulatory Affairs, Dietary Supplements This position reports to the Director, Regulatory Affairs and is based in Skillman. Role reports to: Director, RA Dietary Supplements Location: Summit, NJ Travel %: ...
INDs/CTAs/NDAs/MAAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc)</li><li>Responsible for the development, implementation, and rollout of training to the organization on Regulatory Operations processes and sy...
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 ...