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. ...
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...
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 ...
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 Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulatory environment on selected issues through liaising with trade associations. Associate Director, Regulatory Affairs UK. A new opportunity has arise...
Develop Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan). DVM or Pharm D with 6 years of experience in medical research activities of which 1-3 years should include local/global...
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 Regulatory Affairs management of critical project updates and...
Life Sciences with 4 years in medical research, including 1-3 years of local/global regulatory experience; or MS degree with 6 years industry experience including 1-3 years of local/global regulatory experience; or BS degree with 8 years industry experience including 3-5 years of local/global regula...
The Associate Director of Regulatory Writing is responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. Associate Director, Regulatory Writing Basking Ridge, New Jersey Apply Now. Clinical regulatory documents include, bu...
Prepare, review, and submit regulatory reports, including FR Y-14A, FR Y-14M, FR Y-14Q, FR 2052a, Call Report, and FR Y-9C, in compliance with regulatory requirements and deadlines. Facilitate regulatory audits and examinations by providing necessary documentation and explanations related to the reg...
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 Associate Director/Director, Regulatory Affairs - GDP, provides essential support to the Senior Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory...
Job Summary:The Associate Director of Regulatory Writing is responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. Associate Director, Regulatory Writing Basking Ridge, New Jersey Apply Now. Clinical regulatory documents...
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...
The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios. Associate Director US Regulatory Affairs CMC. The primary responsibilities of this role, Associate Director...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
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...
SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices. You’ll help build too...
Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health. 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 a...
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...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
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...
Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciti...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...