CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Global Health Authoritie. ...
The Regulatory Affairs team at Entrada is a dynamic, growing team that develops and executes innovative regulatory strategies to efficiently advance Entrada’s pipeline of intracellular therapeutics for the treatment of devastating diseases. Reporting to the Senior Vice President, Regulatory Affairs,...
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscap...
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA. Proclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey and Massachusetts. As the PRC Regulatory Affai...
Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registratio...
Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current r...
The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulatory matters of field trials, and supporting other regulato...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory AffairsLocation: Cambridge, MA or Bridgewater, NJAbout the jobThe Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, wor...
Prior experience must include: Vendor and Client Management for Regulatory Operations – Manage relationships with vendors and clients for various regulatory operations services; Identify and evaluate potential eCTD submission vendors based on their experience, expertise, cost-effectiveness, and trac...
Director, Regulatory Affairs U. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam’s marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and...
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (, commercial, research, clinical development, medical affairs, business development, legal, manufacturing, qual...
Responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects, including development and maintenance of the Regulatory Plan, working with the Director of Regulatory Affairs and other colleagues as appropriate. The Associate Director of Regulatory Af...
Director Regulatory Affairs Professional, Ad & Promo. Neurology Regulatory Affairs team of a global biopharmaceutical company as . Director of Regulatory Affairs (Ad & Promo). Responsibilities for the Associate Director of Regulatory Affairs Advertising & Promotion include:. ...
Actively participate in problem solving discussions and recommend solutions • Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies • Assist in the maintenance and improvement of regulatory SOPs • Interact and negoti...
Provide strategic consult on regulatory and clinical matters for Biogen on the following:o Various acquisition scenarios and impactrisk to device regulatory, clinical and businesso Provide high level regulatory requirements for Class III medical devices (investigational and marketing applications in...
The Senior Regulatory Affairs Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team. Regulatory Affairs Manager-(3291838). This position will report to the Director, Legal, Regulatory Affairs & Compliance, and will take the lead on managing a portfolio of federal regulati...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs**+ Location: Bridgewater, NJ or Cambridge, MA**About the job**The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in the Rare Disease, Rare Bl...
The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department. Key Responsibilities: Regulatory Affa...
The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT). Senior Director, Business Planning & Operations, Regulatory Affairs. Works closely wi...
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Senior Regulatory Affairs Specialist. Serve as RA Repre...
Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strateg...
ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all product-related activities (from development to post-commercialization) are conducted in accordance with the current domestic and global regulatory statutes that govern the res...
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties. Significant regulatory affairs experience is required. Provides stra...
Responsible to communicate new regulatory guidelines. Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update ...
Leads the Regulatory Affairs team to design and execute regulatory strategy for approval and commercialization of the company’s products, including preparation, review, and submission of appropriate background documents and regulatory submissions. Keeps executive leadership team informed of regulato...