- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . ... This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global health authorities....of trends and metrics across the development pipeline. The Senior Director will guide and support the… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …their aspirations. Join Kite and help create more tomorrows. **Job Description** The Senior Director , Regulatory Affairs , Advertising and Promotion ... Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs . **Responsibilities:**...ability to work autonomously with minimal oversight from a senior regulatory affairs professional +… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global … more
- BeOne Medicines (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Lilly (Indianapolis, IN)
- …the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Mount Sinai Health System (New York, NY)
- …Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is responsible for assisting the Vice ... President, Quality and Regulatory Affairs , MSHS, in maintaining a state of regulatory compliance across the MSHS, through proactive tracking, communication,… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) role ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... and regulatory operations throughout the organization. The Senior Director of Quality Management Systems &... Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading,… more
- HCA Healthcare (Louisville, KY)
- …Summary and Qualifications** The Senior Director of Accreditation, Compliance, and Regulatory Affairs will lead the College in the areas of regional and ... the lives of many. Jump-start your career as a Senior Director of Accreditation - Compliance -...programmatic accreditation, compliance, regulatory affairs , risk management, and state licensing… more
- Abbott (Lake Forest, IL)
- …Opportunity** Our location in **Lake Forest, IL** currently has an opportunity for the ** Director of Regulatory Affairs .** The function of a Director ... metrics/information. The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide. **WHAT YOU'LL… more
- Walgreens (Deerfield, IL)
- **Job Description:** **Job Summary** The Senior Director of Government Affairs is pivotal in shaping and leading strategies to proactively represent ... staff, business and industry leaders, and professional societies. The Senior Director evaluates and manages legislative and regulatory issues impacting the… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director...Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to… more
- J&J Family of Companies (Spring House, PA)
- …Learn more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for a Director , CMC Regulatory Affairs New Modalities to be in ... Horsham, PA; Titusville, NJ; or Raritan, NJ.** **Purpose:** The Director , CMC Regulatory Affairs New...regulatory requirements and expectations. Communicates critical issues to Senior Management * Represents CMC RA on Cross Functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- IQVIA (Columbia, MD)
- MCRA an IQVIA business is seeking an Director , Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and ... of overall regulatory strategy, and communicating with regulatory bodies and clients. The Director will...current agency experience is required. + 7+ years of regulatory affairs experience required. + 4+ years… more
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