- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports. Review ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Review and interpret regulatory guidelinesContinuing ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with focus on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, ... research areas centered around rare diseases and immune disorders.Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Aequor (Newbury Park, CA)
- … regulatory history documents through systems and appropriately archive all regulatory documents and agency communications Review regional component of the ... Description: In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or provide information/data for regulatory filings.May serve as the single regulatory representative on study teams. Review and interpret regulatory ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Aequor (Thousand Oaks, CA)
- …pivot tables) and author/update MSWord documents. Experience in labeling and Regulatory document management. Experience in promotional review and approval ... Regulatory Affairs Associate - CW Remote EST preferred....of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory … more
- Merck & Co. (North Wales, PA)
- … success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... regulatory leadership as needed in product in-license/due diligence review , product divestment and product withdrawal.Support new technology development.Demonstrate… more
- Eisai, Inc (Nutley, NJ)
- …Continuity: Develop plans to mitigate business interruption risks.Change Management: Create a regulatory / non- regulatory change review and change management ... objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that govern the organization's… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... global activities and regulators.Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDAEnsure GLP… more
- Merck & Co. (North Wales, PA)
- …(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose creative, effective, ... to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and… more
- Genmab (Plainsboro, NJ)
- …on key performance indicators to brand leadersRepresenting the brand during Medical/Legal/ Regulatory review meetings to ensure launch readinessWork effectively ... with Genmab sales leadership (and field sales advisory boards), relevant Genmab functions,Work productively to lead through key internal stakeholders, and cross-functional groups within GenmabDrive engagement and partnerships with relevant patient/caregiver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Merck & Co. (North Wales, PA)
- …Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.Participates in regulatory due ... Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for...approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and… more
- Merck & Co. (Rahway, NJ)
- …the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 may serve as an...Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review … more
- Eisai, Inc (Nutley, NJ)
- …with action Item follow-up Attends CRO and vendor teleconferences as applicable Review regulatory packet for investigational product release Provide user access ... management support ; tracking certifications and maintain statuses of study team members Assist with investigator meeting planning, including entering clinical meetings into Eisai internal systems Attend investigator meeting when applicable Performs other… more
