- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC ,… more
- Aequor (NJ)
- …Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, ... 100 % remote Manager prefers local candidates (will consider non local...phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Takeda Pharmaceuticals (Lexington, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the following ... requirements: Master's degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory… more
- J&J Family of Companies (Titusville, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC ... requirements and expectation + Participates in initiatives within CMC -RA or Global Regulatory Affairs + Conducts due diligence/licensing evaluations where… more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible ... Manager , CMC Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Amgen (New Albany, OH)
- …patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager , CMC . **Live** **What you will do** ... all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a...manufacturing and quality programs throughout product lifecycle. + Provide CMC regulatory strategy for products manufactured at… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate ... **In this role, a typical day might include the following:** * Support CMC /Combination product development activities from a regulatory standpoint during early… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with internal and ... approves manufacturing change requests with limited supervision. + Represents CMC regulatory affairs on teams...regulatory affairs department under supervision of manager . Participates in initiatives internal to RA CMC… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic... Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible ... people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop … more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC ...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
- Actalent (Maryland Heights, MO)
- …will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams ... manager is currently managing both the clinical and CMC portions, and they need someone to come in...need experience working with cross functional teams. The Senior Manager of Regulatory Affairs is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development...and non-promotional materials. + Collaborates closely with the PMRC Manager and other members to quickly resolve issues that… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in our ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC...GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide… more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC ,… more
- WuXi AppTec (Middletown, DE)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
