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 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 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...
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 Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, worki...
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...
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). This position drives/leads the maintenance of global labeling and associated d...
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...
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...
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 ...
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 as needed, act as US agent and communicate with the agency...
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...
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities . Those aren’t words that are usually associated with a job. Develop global and/or US regulatory strategy for Oncology products in development and through life cycle management, ...
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 ...
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...
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...
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...
Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, and competitor analyses) for Target Product Labeling, CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentraliz...
CRM performs work on a variety of regulatory compliance related matters. The CRM team is an oversight control function within BX Central Legal & Compliance designed to assess the effectiveness of BX’ policies and procedures, particularly with respect to regulatory compliance of the BX registered...
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. ...
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. ...
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. ...
We are looking for an entry-level Regulatory Registration Assistant to join our Research & Innovation (R&I) team. This position is a corporate desk job focused on supporting regulatory registration for global product launches. ...
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...