The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collabo...
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
The Associate Director, Global Regulatory Science CMC Therapeutics Programs, will be responsible for leading regulatory CMC strategy and support for products in clinical development (IND, CTA) and commercial product registrations (BLA, MAA), including, post-approval variations. The Associate Direct...
We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. ...
Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lex...
The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the st...
We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Extensive experience with ...
The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory asse...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
GoTo is seeking to add a detail-oriented, tech savvy, and intellectually curious Associate General Counsel and Data Privacy Officer to lead its Privacy and Regulated Technologies legal practice group and help scale and improve its world-class data privacy, cybersecurity, telecommunications, product ...
Associate Director, Regulatory Publishing (Remote). The Regulatory Publishing Associate Director is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent ...
The Associate Director will report into the Regulatory CMC group devoted to developing regulatory CMC strategies that support rapid development of products targeting rare and ultra-rare indications. Working knowledge in the rare disease space and the ability to deal with issues of critical importanc...
The Associate Director, Regulatory Submission Management is responsible for the planning, managing, and tracking of the regulatory portfolio of submissions across a number of assigned programs. Associate Director, Regulatory Submission Management. The role will focus on achieving regulatory submissi...
Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program a...
Manatt, Phelps & Phillips, LLP, is seeking a highly qualified associate with two to four years of health care regulatory experience to join our growing team. Our health care transactions and regulatory team assists with the structuring and negotiation of transactions, provides strategic advice o...
Financial and Regulatory Reporting, TSR Operations Senior Associate, located in either Boston, MA or Kansas City, MO will manage semi-annual and annual TSR regulatory filings for various clients. As Financial and Regulatory Reporting, TSR Operations Senior Associate you will:. Perform 1st, 2nd, risk...
Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. The Associate Director of Regulatory Affairs will be responsible for the development and execution of the regulatory strategy for assigned p...
The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collabo...
Clinical Regulatory Writing (CReW). You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners. Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical subm...
The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or...
Collaborates with other functional work teams , Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projec...
As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...
Manage Energy practice teams in regulatory-focused client engagements, including general and limited-issue rate cases, development of regulatory strategy, and regulatory due diligence for transactions;. Serve as a subject matter expert for clients on ratemaking issues and regulatory strategy;. Perfo...
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...
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...