- Astellas Pharma (Westborough, MA)
- …with local and global stakeholders. **Essential Job Responsibilities:** + Acts as a CMC regulatory lead and/or Deputy for highly complex projects/products ... and/or credibility. **Organizational Context:** Reports to Director or Senior Director, Regulatory Affairs CMC . **Qualifications:** **Required** + BS… more
- Astellas Pharma (Westborough, MA)
- …project or product and the application. **Essential Job Responsibilities:** + Acts as CMC regulatory lead or deputy for complex projects/products, requiring ... Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed to equality of… more
- Merck (Rahway, NJ)
- …Principal Scientist / Director responsibilities include but are not limited to: + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Actalent (Boston, MA)
- …are highly preferred. Experience: + At least 5 years of relevant experience in CMC Regulatory Affairs for biologics, including involvement with IND ... CMC strategies to support gene therapy development. Key Responsibilities + Lead global Regulatory CMC strategic guidance and provide tactical support to… more
- Sanofi Group (Bridgewater, NJ)
- …of Manufacturing & Supply and CMC R&D, collaborating closely with other Global Regulatory Affairs (GRA) and local regulatory functions, and with many ... topics with other health authorities including international with local/regional teams + Lead the Regulatory CMC content of meetings with FDA, EMA, supports… more
- Bristol Myers Squibb (Princeton, NJ)
- …guide technical teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for ... all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the… more
- Bausch + Lomb (Columbus, OH)
- …advancement of eye health in the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and ... surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any other critical topics… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global ... Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early phase, development, submissions and ... a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC /CP prduct development… more
- Regeneron Pharmaceuticals (Troy, NY)
- …this role, a typical day might include the following:** + Lead CMC /CP product development activities from a regulatory standpoint during early phase, ... perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and...input from senior management. + Represent CMC /CP RA at program meetings and independently provide regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the development plans to support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external ... creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm), may be...one or more therapeutic areas, and coordinates strategy with RA project management for assigned regulatory projects.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and activities… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory ... requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including...e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you...Director Global Regulatory Affairs CMC . **How you will contribute:** +... CMC experience including experience as an RA CMC product lead with… more
- Amgen (Washington, DC)
- …for product manufacturing and quality programs throughout product lifecycle **Job Summary** The RA CMC Product Lead is responsible for execution and/ ... strategy for an assigned set of commercial products. The RA CMC Product Lead is...to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and… more
- Danaher Corporation (Chicago, IL)
- …ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department and report to the Vice ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...this role, you will have the opportunity to: + Lead regulatory submissions, including pre-market applications, product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. * Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory...to generate and refine the product development strategy. * Lead preparation of high-quality global clinical trial applications in… more